Needle gauge and tip designs for preventing post‐dural puncture headache (PDPH)

Ingrid Arevalo‐Rodriguez; Luis Muñoz; Natalia Godoy‐Casasbuenas; Agustín Ciapponi; Jimmy J Arevalo; Sabine Boogaard; Marta Roqué i Figuls

doi:10.1002/14651858.CD010807.pub2

Калибр иглы и формы наконечников для предотвращения головной боли после дуральной пункции (ГБПДП)

Appendices

Appendix 1. Glossary of terms

Term	Definition	Source
Analgesia, epidural	Relief of pain without loss of consciousness through the introduction of an analgesic agent into the epidural space of the vertebral canal.	http://www.ncbi.nlm.nih.gov/mesh
Analgesia, obstetric	Elimination of pain, without loss of consciousness, during obstetrical labour; obstetrical delivery; or the postpartum period, usually through the administration of analgesics.	http://www.ncbi.nlm.nih.gov/mesh
Blood patch, epidural	Injection of autologous blood into the epidural space either as a prophylactic treatment immediately after an epidural puncture or for treatment of headache resulting from an epidural puncture.	http://www.ncbi.nlm.nih.gov/mesh
Cerebrospinal fluid pressure	Manometric pressure of the cerebrospinal fluid as measured by lumbar, cerebroventricular or cisternal puncture. Within the cranial cavity, it is called intracranial pressure.	http://www.ncbi.nlm.nih.gov/mesh
Dura mater	The outermost of the three meninges, a fibrous membrane of connective tissue that covers the brain and the spinal cord.	http://www.ncbi.nlm.nih.gov/mesh
Myelography	X‐ray visualization of the spinal cord after injection of contrast medium into the spinal arachnoid space.	http://www.ncbi.nlm.nih.gov/mesh
Needle	Sharp instruments used for puncturing or suturing.	http://www.ncbi.nlm.nih.gov/mesh
Primary prevention	Specific practices for the prevention of disease or mental disorders in susceptible individuals or populations. These include health promotion, including mental health; protective procedures, such as communicable disease control; and monitoring and regulation of environmental pollutants.	http://www.ncbi.nlm.nih.gov/mesh
Post‐dural puncture headache	A secondary headache disorder attributed to low cerebrospinal fluid pressure caused by spinal puncture, usually after dural or lumbar puncture.	http://www.ncbi.nlm.nih.gov/mesh
Spinal puncture	Tapping fluid from the subarachnoid space in the lumbar region, usually between the third and fourth lumbar vertebrae.	http://www.ncbi.nlm.nih.gov/mesh

Appendix 2. CENTRAL, the Cochrane Library search strategy

#1 MeSH descriptor: [Post‐Dural Puncture Headache] explode all trees
#2 (pdph or plph or pph or post dural or postdural or headach* or cephalea* or cephalalgi*):ti,ab
#3 MeSH descriptor: [Anesthesia, Epidural] explode all trees
#4 MeSH descriptor: [Anesthesia, Spinal] explode all trees
#5 MeSH descriptor: [Injections, Spinal] explode all trees
#6 MeSH descriptor: [Myelography] explode all trees
#7 MeSH descriptor: [Spinal Puncture] explode all trees
#8 (#1 or #2) and (#3 or #4 or #5 or #6 or #7)
#9 ((spinal or intraspinal or dural or intradural or epidural or lumbar* or thecal* or intrathecal or sub?arachnoid*) near (puncture* or inject* or anesth* or anaesth* or needle* or tap)):ti,ab
#10 #8 or #9
#11 (caliber or needle gauge* or needle tip* or needle size* or traumatic tap* or traumatic needle* or atraumatic needle* or pencil point* or diamond tip* or spinal needle* or ((quincke or greene or hingson or lutz or brace or rovenstine or lemmon or whitacre or atraucan or sprotte or cappe or gertie marx or deutsch) and (needle*))):ti,ab
#12 #10 and #11

Appendix 3. MEDLINE (PubMed) search strategy

(Post‐Dural Puncture Headache[Mesh] OR PDPH[tiab] OR PLPH[tiab] OR PPH[tiab] OR Post dural[tiab] OR Postdural[tiab] OR Headache[Mesh] OR Headach*[tiab] OR cephalea*[tiab] OR cephalalgi*[tiab]) AND (Anesthesia, Epidural[Mesh] OR Anesthesia, Spinal[Mesh] OR Injections, Spinal[Mesh] OR Myelography[Mesh] OR Spinal Puncture[Mesh] OR ((spinal[tiab] OR intraspinal[tiab] OR dural[tiab] OR intradural[tiab] OR epidural[tiab] OR lumbar*[tiab] OR thecal*[tiab] OR intrathecal[tiab] OR subarachnoid*[tiab] OR sub arachnoid*[tiab]) AND (Spinal Puncture[Mesh] OR puncture*[tiab] OR inject*[tiab] OR anesth*[tiab] OR anaesth*[tiab] OR needle*[tiab] OR Tap[tiab]))) AND (caliber[tiab] OR Needle Gauge*[tiab] OR Needle Tip*[tiab] OR Needle size*[tiab] OR Traumatic Tap*[tiab] OR Traumatic Needle*[tiab] OR Atraumatic Needle*[tiab] OR Pencil Point*[tiab] OR Diamond Tip*[tiab] OR Spinal Needle*[tiab] OR ((Quincke[tiab] OR Greene[tiab] OR Hingson[tiab] OR Lutz[tiab] OR Brace[tiab] OR Rovenstine[tiab] OR Lemmon[tiab] OR Whitacre[tiab] OR Atraucan[tiab] OR Sprotte[tiab] OR Cappe[tiab] OR Gertie Marx[tiab] OR Deutsch[tiab]) AND (Needle*[tiab])))

Appendix 4. EMBASE (Ovid SP) search strategy

1. (postdural puncture headache/ or pdph.ti,ab. or plph.ti,ab. or pph.ti,ab. or post dural.ti,ab. or postdural.ti,ab. or headache/ or headach*.ti,ab. or cephalea*.ti,ab. or cephalalgi*.ti,ab.) and (epidural anesthesia/ or spinal anesthesia/ or intraspinal drug administration/ or myelography/ or puncture/ or ((spinal or intraspinal or dural or intradural or epidural or lumbar* or thecal* or intrathecal or sub?arachnoid*) and (puncture* or inject* or anesth* or anaesth* or needle* or tap)).ti,ab.) and (caliber or needle gauge* or needle tip* or needle size* or traumatic tap* or traumatic needle* or atraumatic needle* or pencil point* or diamond tip* or spinal needle* or ((quincke or greene or hingson or lutz or brace or rovenstine or lemmon or whitacre or atraucan or sprotte or cappe or gertie marx or deutsch) and needle*)).ti,ab.

Appendix 5. CINAHL (EBSCOhost) search strategy

S1. ( (MM "Anesthesia, Epidural") OR (MM "Analgesia, Epidural") OR (MM "Anesthesia, Spinal") OR (MM "Injections, Intraspinal+") OR (MM "Myelography") OR (MH "Spinal Puncture") ) AND ( (MH "Headache") OR TI ( pdph or plph or pph or post dural or postdural or headach* or cephalea* or cephalalgi* ) OR AB ( pdph or plph or pph or post dural or postdural or headach* or cephalea* or cephalalgi* ) )
S2. TI ( (spinal or intraspinal or dural or intradural or epidural or lumbar* or thecal* or intrathecal or subarachnoid* or sub arachnoid*) and (puncture* or inject* or anesth* or anaesth* or needle* or tap) ) OR AB ( (spinal or intraspinal or dural or intradural or epidural or lumbar* or thecal* or intrathecal or subarachnoid* or sub arachnoid*) and (puncture* or inject* or anesth* or anaesth* or needle* or tap) )
S3. S1 OR S2
S4. TI ( (caliber or needle gauge* or needle tip* or needle size* or traumatic tap* or traumatic needle* or atraumatic needle* or pencil point* or diamond tip* or spinal needle* or ((quincke or greene or hingson or lutz or brace or rovenstine or lemmon or whitacre or atraucan or sprotte or cappe or gertie marx or deutsch) and (needle*))) ) OR AB ( (caliber or needle gauge* or needle tip* or needle size* or traumatic tap* or traumatic needle* or atraumatic needle* or pencil point* or diamond tip* or spinal needle* or ((quincke or greene or hingson or lutz or brace or rovenstine or lemmon or whitacre or atraucan or sprotte or cappe or gertie marx or deutsch) and (needle*))) )
S5. S3 AND S4

Appendix 6. LILACS (BIREME) search strategy

((pdph or plph or pph or post dural or postdural or headach$ or cephalea$ or cephalalgi$) and (epidural or spinal anesthesia or spinal injections or myelography or spinal puncture)) or ((spinal or intraspinal or dural or intradural or epidural or lumbar$ or thecal$ or intrathecal or subarachnoid$ or sub arachnoid$) and (puncture$ or inject$ or anesth$ or anaesth$ or needle$ or tap)) [Words] and (caliber or needle gauge$ or needle tip$ or needle size$ or traumatic tap$ or traumatic needle$ or atraumatic needle$ or pencil point$ or diamond tip$ or spinal needle$ or ((quincke or greene or hingson or lutz or brace or rovenstine or lemmon or whitacre or atraucan or sprotte or cappe or gertie marx or deutsch) and (needle$)))

Appendix 7. Study eligibility screening and data extraction form

Needle Gauge and Tip designs for Preventing PDPH — Intervention Cochrane Review

Study Selection, Quality Assessment & Data Extraction Form

First Author	Journal/Conference proceedings, etc	Year

1. Study Eligibility

	RCT/CCT	Relevant participants	Relevant interventions	Relevant outcomes*
Yes
No
Unclear

^aIssues related to selective reporting when authors may have taken measurements for particular outcomes but did not report these within the paper(s). Review authors should contact trialists for information on possible non‐reported outcomes and reasons for exclusion from publication. Study should be listed in 'Studies awaiting assessment' until clarified. If no clarification is received after three attempts, study should then be excluded.

‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Do not proceed if any of the above answers is "No".

2. References to Trial

Check other references identified in searches. If further references to this trial are identified, link the papers and list below. All references to a trial should be linked under one Study ID in RevMan.

Author	Journal/Conference proceedings, etc	Year

3. Participant and Trial Characteristics

	Further details
Age, years (mean, median, range, etc.)
Gender of participants
Country
Reason for puncture (dx, anaesthesia, radiology)
Surgical procedure (obstetrical, orthopaedic, etc.)
Type of anaesthesia used
Trial design (parallel, etc.)
Single centre/multi‐centre
Eligibility criteria
Exclusion criteria
Follow‐up, years (mean, median, range, etc.)
Time points reported in the study
Other

4. Intervention Characteristics

	Further details
Needle tip
Needle gauge
Number of attempts

5. Number of Participants

	Enrolled participants	Randomly assigned participants	Participants included in analysis	Lost to follow‐up	Reasons
At beginning
A Group
B Group
C Group
D Group

6. Methodological Quality

	Low risk of bias	Unclear risk of bias	High risk of bias	Details
Random sequence generation
Allocation concealment
Blinding of participants and personnel
Blinding of outcome assessment
Selective reporting bias
Incomplete outcome data
Other bias
Withdrawals
Other (describe)

7. Results

	A Group (define)		B Group (define)
	# Participants with outcome	# Participants analysed	# Participants with outcome	# Participants analysed
PDPH
Severe PDPH (define)
Any headache after spinal anaesthesia
Other (define)

Figure 1

Study flow diagram

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 4

Forest plot of comparison: 1 Traumatic needle versus atraumatic needle, outcome: 1.1 PDPH by indication.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 5

Funnel plot of comparison: 1 Traumatic needle versus atraumatic needle, outcome: 1.1 PDPH by indication.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 6

Funnel plot of comparison: 3 Atraumatic needles: different gauges, outcome: 3.1 PDPH major gauge versus minor gauge by number.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.1

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 1 PDPH by indication.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.2

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 2 PDPH by gauge.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.3

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 3 PDPH by gender.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.4

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 4 PDPH/anaesthesia: type of surgery.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.5

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 5 PDPH by position.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.6

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 6 PDPH by age.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.7

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 7 AE: paraesthesia.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.8

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 8 AE: backache.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.9

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 9 Severe PDPH by indication.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.10

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 10 Any headache by indication.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.11

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 11 PDPH sensitivity analysis.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.1

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 1 PDPH larger gauge vs smaller gauge.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.2

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 2 PDPH by type of surgery.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.3

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 3 PDPH by age.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.4

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 4 PDPH by position.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.5

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 5 AE: backache.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.6

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 6 Severe PDPH by gauge.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.7

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 7 Any headache.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.1

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 1 PDPH larger gauge vs smaller gauge.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.2

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 2 PDPH by type of surgery.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.3

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 3 PDPH by gender.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.4

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 4 PDPH by position.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.5

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 5 AE: paraesthesia.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.6

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 6 AE: backache.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.7

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 7 Severe PDPH by gauge.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.8

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 8 Any headache by gauge.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Summary of findings for the main comparison. Traumatic needles compared to atraumatic needles for prevention of post‐dural puncture headache (PDPH)

Traumatic needles compared to atraumatic needles for prevention of PDPH
Patient or population: patients undergoing lumbar punctures Settings: all settings (countries: Argentina, Austria, Brazil, Canada, Denmark, Finland, France, Germany, India, Israel, Italy, Korea, Mexico, Nepal, Netherlands, Nigeria, Norway, Pakistan, Spain, Thailand, UK and USA) Intervention: traumatic needles (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon) Comparison: atraumatic needles (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Atraumatic needles	Traumatic needles
Onset of PDPH	30 per 1000	64 per 1000 (52 to 80)	RR 2.14 (1.72 to 2.67)	9378 (36 studies)	⊕⊕⊕⊝ moderate¹	—
Adverse events: paraesthesia	52 per 1000	50 per 1000 (25 to 102)	RR 0.96 (0.47 to 1.96)	573 (3 studies)	⊕⊕⊕⊝ moderate¹	—
Adverse events: backache	155 per 1000	147 per 1000 (118 to 183)	RR 0.94 (0.78 to 1.13)	3027 (12 studies)	⊕⊕⊕⊝ moderate¹	—
Severe PDPH	0 per 1000	10 per 1000	RD 0 (0.00 to 0.01)	6420 (24 studies)	⊕⊕⊝⊝ low^1,2	—
Any headache	221 per 1000	290 per 1000 (228 to 367)	RR 1.35 (1.17 to 1.57)	4104 (18 studies)	⊕⊕⊕⊝ moderate¹	—
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues). ²Inconsistency downgraded by one level due to presence of considerable heterogeneity (I² = 42%), caused by one study focused on diagnostic lumbar punctures (Muller 1994).

Summary of findings for the main comparison. Traumatic needles compared to atraumatic needles for prevention of post‐dural puncture headache (PDPH)

Ir a la tabla de la revisión

Summary of findings 2. Larger traumatic needles compared to smaller traumatic needles for prevention of post‐dural puncture headache (PDPH)

Traumatic needle(major gauge) compared to traumatic needle (minor gauge) for prevention of PDPH
Patient or population: patients undergoing lumbar punctures with traumatic needles (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon) Settings: all settings (countries: Finland, Germany, India, Italy, Korea, Pakistan and USA) Intervention: traumatic needle ‐ larger gauge (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon) Comparison: traumatic needle ‐ smaller gauge (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Traumatic needle ‐ smaller gauge	Traumatic needle ‐ larger gauge
Onset of PDPH	—	—	RR ranged from 0.86 to 6.47	2288 (10 studies)	⊕⊕⊝⊝ low^1,3	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.
Adverse events: paraesthesia ‐ not reported	See comment	See comment	Not estimable	—	See comment	We did not identify any studies reporting this outcome.
Adverse event: backache	—	—	RR ranged from 0.81 to 2.00	948 (3 studies)	⊕⊕⊕⊝ moderate¹	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.
Severe PDPH	—	—	RD ranged from 0.00 to 0.00	1128 (6 studies)	⊕⊕⊝⊝ low^1,2	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.
Any headache	—	—	RR ranged from 0.75 to 1.56	771 (3 studies)	⊕⊕⊕⊝ moderate¹	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues). ²Imprecision downgraded by one level due to few events reported in each arm. ³Imprecision downgraded by one level due unclear clinical decisions indicated by each confidence interval limit.

Summary of findings 2. Larger traumatic needles compared to smaller traumatic needles for prevention of post‐dural puncture headache (PDPH)

Ir a la tabla de la revisión

Summary of findings 3. Larger atraumatic needles compared to smaller atraumatic needles for prevention of post‐dural puncture headache (PDPH)

Atraumatic needle (major gauge) compared to atraumatic needle (minor gauge) for prevention of PDPH
Patient or population: patients undergoing lumbar punctures with atraumatic needles (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor) Settings: all settings (countries: Canada, France, India, Italy, Spain, UK and USA) Intervention: atraumatic needle ‐ larger gauge (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor) Comparison: atraumatic needle ‐ smaller gauge (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Atraumatic needle ‐ smaller gauge	Atraumatic needle ‐ larger gauge
Onset of PDPH	—	—	RR ranged from 0.38 to 9.3	3134 (13 studies)	⊕⊕⊝⊝ low^1,2	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.
Adverse events: paraesthesia	—	—	RR ranged from 1.03 to 7.61	439 (2 studies)	⊕⊕⊕⊝ moderate¹	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.
Adverse events: backache	—	—	RR ranged from 0.95 to 5.00	526 (4 studies)	⊕⊕⊕⊝ moderate¹	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.
Severe PDPH	—	—	RD ranged from 0 to 0.01	1983 (8 studies)	⊕⊕⊝⊝ low^1,2	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.
Any headache	—	—	RR ranged from 1.13 to 2.17	1791 (7 studies)	⊕⊕⊕⊝ moderate¹	We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues). ²Imprecision downgraded by one level due unclear clinical decisions indicated by each confidence interval limit.

Summary of findings 3. Larger atraumatic needles compared to smaller atraumatic needles for prevention of post‐dural puncture headache (PDPH)

Ir a la tabla de la revisión

Comparison 1. Traumatic needle versus atraumatic needle

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PDPH by indication Show forest plot	36	9378	Risk Ratio (M‐H, Random, 95% CI)	2.14 [1.72, 2.67]

1.1 Anaesthesia only	30	8401	Risk Ratio (M‐H, Random, 95% CI)	2.21 [1.60, 3.04]
1.2 Myelography only	3	548	Risk Ratio (M‐H, Random, 95% CI)	2.01 [1.34, 3.00]
1.3 Diagnostic lumbar puncture only	3	429	Risk Ratio (M‐H, Random, 95% CI)	2.22 [1.38, 3.58]
2 PDPH by gauge Show forest plot	20		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 22 gauge	5	877	Risk Ratio (M‐H, Random, 95% CI)	2.15 [1.56, 2.97]
2.2 25 gauge	5	1260	Risk Ratio (M‐H, Random, 95% CI)	2.48 [1.56, 3.95]
2.3 27 gauge	11	4076	Risk Ratio (M‐H, Random, 95% CI)	2.87 [1.81, 4.53]
3 PDPH by gender Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Only women	9	1424	Risk Ratio (M‐H, Random, 95% CI)	2.60 [1.62, 4.17]
4 PDPH/anaesthesia: type of surgery Show forest plot	30		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Caesarean section	8	1324	Risk Ratio (M‐H, Random, 95% CI)	3.12 [1.60, 6.10]
4.2 Orthopaedic procedures	3	994	Risk Ratio (M‐H, Random, 95% CI)	1.35 [0.58, 3.19]
4.3 Other surgeries	19	6083	Risk Ratio (M‐H, Random, 95% CI)	2.30 [1.50, 3.51]
5 PDPH by position Show forest plot	20		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Lateral position	9	3242	Risk Ratio (M‐H, Random, 95% CI)	4.70 [2.39, 9.24]
5.2 Sitting position	11	2193	Risk Ratio (M‐H, Random, 95% CI)	2.11 [1.52, 2.94]
6 PDPH by age Show forest plot	36		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 No distinctions by age	34	9063	Risk Ratio (M‐H, Random, 95% CI)	2.17 [1.73, 2.73]
6.2 Only < 18 years	2	315	Risk Ratio (M‐H, Random, 95% CI)	1.69 [0.56, 5.12]
7 AE: paraesthesia Show forest plot	3	573	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.47, 1.96]

8 AE: backache Show forest plot	12	3027	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.78, 1.13]

9 Severe PDPH by indication Show forest plot	24	6420	Risk Ratio (M‐H, Random, 95% CI)	1.88 [1.20, 2.94]

9.1 Anesthesia	19	5542	Risk Ratio (M‐H, Random, 95% CI)	1.77 [0.88, 3.53]
9.2 Myelography	4	778	Risk Ratio (M‐H, Random, 95% CI)	1.70 [0.68, 4.28]
9.3 Diagnostic lumbar puncture	1	100	Risk Ratio (M‐H, Random, 95% CI)	3.0 [1.18, 7.63]
10 Any headache by indication Show forest plot	18	4104	Risk Ratio (M‐H, Random, 95% CI)	1.35 [1.17, 1.57]

10.1 Anaesthesia	16	3656	Risk Ratio (M‐H, Random, 95% CI)	1.38 [1.17, 1.63]
10.2 Myelography	2	448	Risk Ratio (M‐H, Random, 95% CI)	1.34 [0.81, 2.21]
11 PDPH sensitivity analysis Show forest plot	3	802	Risk Ratio (M‐H, Random, 95% CI)	2.78 [1.26, 6.15]

Comparison 1. Traumatic needle versus atraumatic needle

Ir a la tabla de la revisión

Comparison 2. Larger gauge traumatic needles versus smaller gauge traumatic needles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PDPH larger gauge vs smaller gauge Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 23 G vs 25 G	1	53	Risk Ratio (M‐H, Random, 95% CI)	2.08 [0.20, 21.55]
1.2 25 G vs 27 G	4	1041	Risk Ratio (M‐H, Random, 95% CI)	1.82 [0.98, 3.39]
1.3 25 G vs 29 G	3	376	Risk Ratio (M‐H, Random, 95% CI)	2.13 [0.46, 9.78]
1.4 26 G vs 27 G	1	658	Risk Ratio (M‐H, Random, 95% CI)	6.47 [2.55, 16.43]
1.5 21 G vs 25 G	1	160	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.30, 2.44]
2 PDPH by type of surgery Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Caesarean section	2	455	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.64, 2.57]
2.2 Orthopaedic surgeries	2	213	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.38, 2.58]
2.3 Other surgeries	6	1620	Risk Ratio (M‐H, Random, 95% CI)	2.94 [1.23, 7.03]
3 PDPH by age Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 No distinctions about age	8	2175	Risk Ratio (M‐H, Random, 95% CI)	2.09 [1.11, 3.95]
3.2 Only children	1	60	Risk Ratio (M‐H, Random, 95% CI)	3.0 [0.13, 70.83]
3.3 Only > 60 years	1	53	Risk Ratio (M‐H, Random, 95% CI)	2.08 [0.20, 21.55]
4 PDPH by position Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Lateral position	5	859	Risk Ratio (M‐H, Random, 95% CI)	1.76 [0.98, 3.16]
4.2 Sitting position	2	584	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.64, 1.56]
5 AE: backache Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6 Severe PDPH by gauge Show forest plot	6		Risk Difference (M‐H, Random, 95% CI)	Subtotals only

6.1 23 G vs 25 G	1	53	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.07, 0.07]
6.2 25 G vs 27 G	3	815	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.01, 0.01]
6.3 25 G vs 29 G	1	100	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.04, 0.04]
6.4 21 G vs 25 G	1	160	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.02, 0.02]
7 Any headache Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

Comparison 2. Larger gauge traumatic needles versus smaller gauge traumatic needles

Ir a la tabla de la revisión

Comparison 3. Larger gauge atraumatic needles versus smaller gauge atraumatic needles

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 PDPH larger gauge vs smaller gauge Show forest plot	13		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 22 G vs 24 G	1	375	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.20, 4.81]
1.2 22 G vs 25 G	2	334	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.32, 28.50]
1.3 24 G vs 25 G	2	647	Risk Ratio (M‐H, Random, 95% CI)	5.62 [1.00, 31.67]
1.4 25 G vs 26 G	3	519	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.30, 1.90]
1.5 25 G vs 27 G	2	612	Risk Ratio (M‐H, Random, 95% CI)	3.72 [0.59, 23.64]
1.6 26 G vs 27 G	2	258	Risk Ratio (M‐H, Random, 95% CI)	1.79 [0.30, 10.73]
1.7 27 G vs 29 G	1	389	Risk Ratio (M‐H, Random, 95% CI)	1.59 [0.58, 4.37]
2 PDPH by type of surgery Show forest plot	13		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Caesarean section	6	1263	Risk Ratio (M‐H, Random, 95% CI)	1.92 [0.64, 5.79]
2.2 Orthopaedic procedures	2	392	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.30, 5.07]
2.3 Other surgeries	5	1479	Risk Ratio (M‐H, Random, 95% CI)	1.44 [0.73, 2.83]
3 PDPH by gender Show forest plot	8		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Only women	8	1853	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.51, 2.20]
4 PDPH by position Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Sitting position	5	1106	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.45, 2.06]
4.2 Lateral position	5	992	Risk Ratio (M‐H, Random, 95% CI)	1.88 [0.65, 5.41]
5 AE: paraesthesia Show forest plot	2	439	Risk Ratio (M‐H, Random, 95% CI)	2.19 [0.31, 15.30]

6 AE: backache Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7 Severe PDPH by gauge Show forest plot	8		Risk Difference (M‐H, Random, 95% CI)	Subtotals only

7.1 22 G vs 24 G	1	375	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.01, 0.01]
7.2 22 G vs 25 G	1	234	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.02, 0.02]
7.3 24 G vs 25 G	1	304	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.02, 0.03]
7.4 25 G vs 26 G	2	311	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.01, 0.03]
7.5 25 G vs 27 G	1	212	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.02, 0.04]
7.6 26 G vs 27 G	1	158	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.02, 0.02]
7.7 27 G vs 29 G	1	389	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.01, 0.01]
8 Any headache by gauge Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 22 G vs 25 G	1	234	Risk Ratio (M‐H, Random, 95% CI)	2.17 [0.85, 5.51]
8.2 24 G vs 25 G	2	645	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.49, 2.77]
8.3 25 G vs 26 G	2	311	Risk Ratio (M‐H, Random, 95% CI)	1.13 [0.65, 1.99]
8.4 25 G vs 27 G	1	212	Risk Ratio (M‐H, Random, 95% CI)	1.87 [0.65, 5.39]
8.5 27 G vs 29 G	1	389	Risk Ratio (M‐H, Random, 95% CI)	1.80 [0.85, 3.83]

Comparison 3. Larger gauge atraumatic needles versus smaller gauge atraumatic needles

Ir a la tabla de la revisión

The Cochrane Library

Scolaris Language Selector Scolaris Language Selector

Idioma de la Revisión Cochrane

Idioma de la web

Scolaris Content Language Banner Portlet Scolaris Content Language Banner Portlet

Scolaris Content Display Scolaris Content Display

Калибр иглы и формы наконечников для предотвращения головной боли после дуральной пункции (ГБПДП)

Appendices

Appendix 1. Glossary of terms

Appendix 2. CENTRAL, the Cochrane Library search strategy

Appendix 3. MEDLINE (PubMed) search strategy

Appendix 4. EMBASE (Ovid SP) search strategy

Appendix 5. CINAHL (EBSCOhost) search strategy

Appendix 6. LILACS (BIREME) search strategy

Appendix 7. Study eligibility screening and data extraction form

Scolaris Language Selector Scolaris Language Selector

Scolaris Content Display Scolaris Content Display

Instituciones a las que se accedió previamente

Scolaris Content Display Scolaris Content Display

Usuarios institucionales

Instituciones a las que se accedió previamente

Otras opciones de acceso

	Idioma de la Revisión Cochrane Escoja su idioma de preferencia para las revisiones Cochrane y otros contenidos. Las secciones sin una traducción aparecerán en inglés.

	Idioma de la web Escoja su idioma de preferencia para la web de la Biblioteca Cochrane.

Idioma de la Revisión Cochrane

Idioma de la web

Appendices

Appendix 1. Glossary of terms

Appendix 2. CENTRAL, the Cochrane Library search strategy

Appendix 3. MEDLINE (PubMed) search strategy

Appendix 4. EMBASE (Ovid SP) search strategy

Appendix 5. CINAHL (EBSCOhost) search strategy

Appendix 6. LILACS (BIREME) search strategy

Appendix 7. Study eligibility screening and data extraction form

Copiar o descargar referencia

Idioma de la Revisión Cochrane

Idioma de la web

Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

Otras opciones de acceso