Combined spinal‐epidural versus spinal anaesthesia for caesarean section

Scott W Simmons; Alicia T Dennis; Allan M Cyna; Matthew G Richardson; Matthew R Bright

doi:10.1002/14651858.CD008100.pub2

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

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

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Analysis 1.1

Comparison 1 CSE versus high‐dose spinal, Outcome 1 Number of women requiring a repeat regional block or a general anaesthetic as a result of failure to establish adequate initial blockade.

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Analysis 1.2

Comparison 1 CSE versus high‐dose spinal, Outcome 2 Number of women requiring supplemental intra‐operative analgesia at any time after CSE or spinal anaesthetic insertion.

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Analysis 1.3

Comparison 1 CSE versus high‐dose spinal, Outcome 3 Number of women requiring intra‐operative conversion to general anaesthesia.

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Analysis 1.4

Comparison 1 CSE versus high‐dose spinal, Outcome 4 Number of women satisfied with anaesthesia.

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Analysis 1.5

Comparison 1 CSE versus high‐dose spinal, Outcome 5 Mean time from start of the regional anaesthetic to effective anaesthesia for surgery.

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Analysis 1.6

Comparison 1 CSE versus high‐dose spinal, Outcome 6 Number of women with hypotension.

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Analysis 1.7

Comparison 1 CSE versus high‐dose spinal, Outcome 7 Number of women with nausea or vomiting or both.

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Analysis 1.8

Comparison 1 CSE versus high‐dose spinal, Outcome 8 Number of women with a post‐dural puncture headache.

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Analysis 1.9

Comparison 1 CSE versus high‐dose spinal, Outcome 9 Mean umbilical artery pH at delivery.

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Analysis 1.10

Comparison 1 CSE versus high‐dose spinal, Outcome 10 Number of neonates with Apgar less than 7 at 5 minutes.

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Analysis 2.1

Comparison 2 CSE versus low‐dose spinal, Outcome 1 Number of women requiring a repeat regional block or a general anaesthetic as a result of failure to establish adequate initial blockade.

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Analysis 2.2

Comparison 2 CSE versus low‐dose spinal, Outcome 2 Number of women requiring supplemental intra‐operative analgesia at any time after CSE or spinal anaesthetic insertion.

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Analysis 2.3

Comparison 2 CSE versus low‐dose spinal, Outcome 3 Number of women requiring intra‐operative conversion to general anaesthesia.

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Analysis 2.4

Comparison 2 CSE versus low‐dose spinal, Outcome 4 Mean time from start of the regional anaesthetic to effective anaesthesia for surgery.

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Analysis 2.5

Comparison 2 CSE versus low‐dose spinal, Outcome 5 Number of women with hypotension.

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Analysis 2.6

Comparison 2 CSE versus low‐dose spinal, Outcome 6 Number of women with nausea or vomiting or both.

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Analysis 2.7

Comparison 2 CSE versus low‐dose spinal, Outcome 7 Number of women with a post‐dural puncture headache.

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Analysis 2.8

Comparison 2 CSE versus low‐dose spinal, Outcome 8 Mean umbilical artery pH at delivery.

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Analysis 2.9

Comparison 2 CSE versus low‐dose spinal, Outcome 9 Number of neonates with Apgar less than 7 at 5 minutes.

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Summary of findings for the main comparison. Combined spinal‐epidural compared to high‐dose spinal for caesarean section

CSE compared to high‐dose spinal for caesarean section
Patient or population: women having a caesarean section Setting: university or national hospitals Intervention: combined spinal‐epidural Comparison: high‐dose spinal
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with high‐dose spinal	Risk with CSE
Number of women requiring a repeat regional block or a general anaesthetic as a result of failure to establish adequate initial blockade	Study population		RR 0.32 (0.05 to 1.97)	341 (7 RCTs)	⊕⊕⊝⊝ LOW ^a,b	‐
	69 per 1000	22 per 1000 (3 to 136)
Number of women requiring supplemental intra‐operative analgesia at any time after CSE or spinal anaesthetic insertion	Study population		Average RR 1.25 (0.19 to 8.43)	390 (7 RCTs)	⊕⊝⊝⊝ VERY LOW^a,c,d	‐
	124 per 1000	154 per 1000 (23 to 1000)
Number of women requiring intra‐operative conversion to general anaesthesia	Study population		RR 1.00 (0.07 to 14.95)	388 (7 RCTs)	⊕⊝⊝⊝ VERY LOW ^e,f	‐
	48 per 1000	48 per 1000 (3 to 712)
Number of women satisfied with anaesthesia	Study population		RR 0.93 (0.73 to 1.19)	72 (2 RCTs)	⊕⊝⊝⊝ VERY LOW^e,g	‐
	806 per 1000	749 per 1000 (588 to 959)
*The risk in the intervention group (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; RCT: randomised controlled trial; RR: Risk ratio.
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
^aSmall sample size and wide confidence interval crossing the line of no effect (imprecision −1). ^bRisk of bias: half of the trials were unclear for selection bias, all of the trials were either unclear or high risk for performance bias, only two trials were at low risk of bias for detection bias, one trial was at unclear risk of attrition bias and two trials were at a high risk of other bias (limitations in study design −1). ^cRisk of bias: one trial at high risk of attrition bias, the other trial had high risk of bias for allocation concealment, other bias, and unclear risk of detection bias (limitations in study design −1). ^dVery small sample size and wide confidence interval crossing the line of no effect (imprecision −2). ^eUnexplained heterogeneity, I² = 65% (inconsistency −1). ^fRisk of bias: the one trial reporting any events for this outcome was at unclear risk of selection bias and at high risk of both detection and performance bias (limitations in study design −1). ^gRisk of bias: both trials were at unclear risk of selection bias. For detection and performance bias, one trial was at unclear risk of bias and the other trial was high risk of bias (limitations in study design −1).

Summary of findings for the main comparison. Combined spinal‐epidural compared to high‐dose spinal for caesarean section

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Summary of findings 2. Combined spinal‐epidural compared to low‐dose spinal for caesarean section

CSE compared to low‐dose spinal for caesarean section
Patient or population: women having a caesarean section Setting: university or national hospitals Intervention: combined spinal‐epidural Comparison: low‐dose spinal
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with low‐dose spinal	Risk with CSE
Number of women requiring a repeat regional block or a general anaesthetic as a result of failure to establish adequate initial blockade	Study population		RR 4.81 (0.24 to 97.80)	224 (3 RCTs)	⊕⊕⊝⊝ LOW^a	‐
	0 per 1000	0 per 1000 (0 to 0)
Number of women requiring supplemental intra‐operative analgesia at any time after CSE or spinal anaesthetic insertion	Study population		RR 1.75 (0.78 to 3.92)	298 (4 RCTs)	⊕⊕⊕⊝ MODERATE^b	‐
	100 per 1000	175 per 1000 (78 to 392)
Number of women requiring intra‐operative conversion to general anaesthesia	Study population		‐	222 (3 RCTs)	⊕⊕⊝⊝ LOW^c	Effect is uncertain. No women in these 3 RCTs required a conversion to general anaesthetic
	see comment	see comment
Number of women satisfied with anaesthesia	Study population		‐	(0 studies)	‐	No data available in the included studies
	see comment	see comment
*The risk in the intervention group (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; RCT: randomised controlled trial RR: Risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
^aSmall sample size and very wide confidence interval crossing the line of no effect (imprecision −2). ^bSmall sample size and wide confidence interval crossing the line of no effect (imprecision −1). ³Small sample size and zero events (imprecision −2).

Summary of findings 2. Combined spinal‐epidural compared to low‐dose spinal for caesarean section

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Table 1. Categorisation of studies by subgroup

	CSE: Needle‐through‐needle			CSE: Two injection
SPINAL	No ED use	Sequential	EVE	No ED use	Sequential	EVE
High‐dose	Horstman 2009 Ithnin 2006 Lim 2006 Ross 2014 Macfarlane 2009 McAndrew 2003	Thoren 1994 Uysallar 2011 Salman 2013 Kim 1995 Kim 1997	Salman 2013	‐	‐	‐
Low‐dose	Tyagi 2009	Choi 2006 Kim 2003	Fabris 2013a Tyagi 2009 Lew 2004	‐	Brizzi 2005	‐
Abizanda 2007 is not included in this table as the doses of drugs used and the mode of administration were not stated

Table 1. Categorisation of studies by subgroup

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Comparison 1. CSE versus high‐dose spinal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of women requiring a repeat regional block or a general anaesthetic as a result of failure to establish adequate initial blockade Show forest plot	7	341	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.05, 1.97]

1.1 No ED use CSE versus high dose spinal	5	259	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.05, 1.97]
1.2 Sequential CSE versus high dose spinal	2	82	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Number of women requiring supplemental intra‐operative analgesia at any time after CSE or spinal anaesthetic insertion Show forest plot	7	390	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.19, 8.43]

2.1 No ED use CSE versus high dose spinal	4	170	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Sequential CSE versus high dose spinal	3	151	Risk Ratio (M‐H, Random, 95% CI)	1.99 [0.18, 21.49]
2.3 EVE CSE versus high dose spinal	1	69	Risk Ratio (M‐H, Random, 95% CI)	0.18 [0.01, 4.28]
3 Number of women requiring intra‐operative conversion to general anaesthesia Show forest plot	7	388	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.07, 14.95]

3.1 No ED use CSE versus high dose spinal	4	168	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Sequential CSE versus high dose spinal	3	151	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.07, 14.95]
3.3 EVE CSE versus high dose spinal	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Number of women satisfied with anaesthesia Show forest plot	2	72	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.73, 1.19]

4.1 Sequential CSE versus high dose spinal	2	72	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.73, 1.19]
5 Mean time from start of the regional anaesthetic to effective anaesthesia for surgery Show forest plot	5		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

6 Number of women with hypotension Show forest plot	4	162	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.76, 1.33]

7 Number of women with nausea or vomiting or both Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	2.17 [1.02, 4.61]

8 Number of women with a post‐dural puncture headache Show forest plot	3	113	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.32, 2.15]

9 Mean umbilical artery pH at delivery Show forest plot	1	40	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.18 [‐0.80, 0.44]

10 Number of neonates with Apgar less than 7 at 5 minutes Show forest plot	4	182	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. CSE versus high‐dose spinal

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Comparison 2. CSE versus low‐dose spinal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of women requiring a repeat regional block or a general anaesthetic as a result of failure to establish adequate initial blockade Show forest plot	3	224	Risk Ratio (M‐H, Fixed, 95% CI)	4.81 [0.24, 97.80]

1.1 No ED use CSE versus low dose spinal	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Sequential CSE versus low dose spinal	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	4.81 [0.24, 97.80]
1.3 EVE CSE versus low dose spinal	2	92	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Number of women requiring supplemental intra‐operative analgesia at any time after CSE or spinal anaesthetic insertion Show forest plot	4	298	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.78, 3.92]

2.1 No ED use CSE versus low dose spinal	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Sequential CSE versus low dose spinal	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 EVE CSE versus low dose spinal	3	168	Risk Ratio (M‐H, Fixed, 95% CI)	1.75 [0.78, 3.92]
3 Number of women requiring intra‐operative conversion to general anaesthesia Show forest plot	3	222	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3.1 No ED use CSE versus low dose spinal	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Sequential CSE versus low dose spinal	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 EVE CSE versus low dose spinal	2	92	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Mean time from start of the regional anaesthetic to effective anaesthesia for surgery Show forest plot	2	160	Std. Mean Difference (IV, Fixed, 95% CI)	0.85 [0.52, 1.18]

5 Number of women with hypotension Show forest plot	4	336	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.38, 0.93]

6 Number of women with nausea or vomiting or both Show forest plot	1	100	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.13, 1.89]

7 Number of women with a post‐dural puncture headache Show forest plot	2	138	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

8 Mean umbilical artery pH at delivery Show forest plot	1	76	Std. Mean Difference (IV, Fixed, 95% CI)	1.17 [0.68, 1.66]

9 Number of neonates with Apgar less than 7 at 5 minutes Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. CSE versus low‐dose spinal

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