Regional analgesia for improvement of long‐term functional outcome after elective large joint replacement

Arthur Atchabahian; Gary Schwartz; Charles B Hall; Claudette M Lajam; Michael H Andreae

doi:10.1002/14651858.CD010278.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 Functional outcome at 3 months, Outcome 1 Knee flexion.

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Analysis 1.2

Comparison 1 Functional outcome at 3 months, Outcome 2 Knee flexion (Infiltration only).

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Summary of findings for the main comparison. Regional anaesthesia compared to conventional pain control for total knee replacement patients: joint functional outcome (Knee Society Score compared to preoperative value), 3 and 6 months after surgery

Regional anaesthesia compared to conventional pain control for total knee replacement patients
Patient or population: total knee replacement patients Settings: university hospital Intervention: regional analgesia Comparison: conventional pain control
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Conventional pain control	Regional analgesia
Knee Society Score compared to preoperative value Follow‐up: 3 months	The mean Knee Society Score compared to preoperative value in the control group was + 42.87 points	The mean Knee Society Score compared to preoperative value in the intervention group was 1.76 points higher	Impossible to estimate as no standard deviation was provided	30 participants (1 study)	⊕⊝⊝⊝ very low^a,b,c,d,e
Knee Society Score compared to preoperative value Follow‐up: 6 months	The mean Knee Society Score compared to preoperative value in the control group was + 44.70 points	The mean Knee Society Score compared to preoperative value in the intervention group was 4.03 points higher	Impossible to estimate as no standard deviation was provided	30 participants (1 study)	⊕⊝⊝⊝ very low^a,b,c,d,e
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.
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.
^aUnclear risk of detection bias (unclear outcome observer blinding), especially as pain is a subjective assessment. ^bProvider and participants were unblinded, especially as pain is a subjective assessment. ^cHigh risk of attrition bias. Nineteen participants were enrolled, then excluded, but were not included in the analysis. ^dOnly one study could be included. ^eThe quality of the evidence was downgraded from high to very low.

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Summary of findings 2. Regional anaesthesia compared to conventional pain control for total knee replacement patients: knee flexion 3 months after surgery (as a surrogate for joint functional outcome)

Regional anaesthesia compared to conventional pain control for total knee replacement patients
Patient or population: total knee replacement patients Settings: university Hospital Intervention: regional analgesia Comparison: conventional pain control
Outcomes	*Illustrative comparative risks (95% CI)**		No. of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Conventional pain control	Regional Analgesia
Knee flexion Range of motion assessment Follow‐up: mean 3 months	The mean knee flexion ranged across control groups from 110 to 140 degrees of flexion	The mean knee flexion in the intervention groups was 4 higher (2.23 lower to 10.21 higher)	140 (3 studies)	⊕⊝⊝⊝ very low^a,b,c,d,e
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.
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.
^aHigh or unclear risk of detection bias (unclear outcome observer blinding), especially as pain is a subjective assessment. ^bProvider and participants were partially unblinded, especially as pain is a subjective assessment. ^cStudies showed heterogeneous results. ^dThe confidence interval of the effect estimate is wide. The pooled effect is not statistically significant. ^eThe quality of the evidence was downgraded from high to very low.

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Table 1. Overview of included studies

Study Blinding^a	Population: Enrolled/analysed/followed up to at least 3 months (no. per group)	Intervention(s)	Control	Postoperative outcomes
Kadic 2009 Single	58/53/48 (27/26)	CFNB	No block	Knee function after 3 months (knee flexion, Knee Society score and WOMAC pain, stiffness and function subscale)
Nader 2012 Unblinded	62/62/60 (31/31)	CFNB (Epidural infusion until morning of POD 1)	No block (epidural infusion until morning of POD 1)	Knee flexion at 1, 6 and 12 months Functional outcome on POD 1, POD 2, POD 3, 1 month, 6 months, and 12 months
Singelyn 1998 Unblinded	45/45/45 (15/15/15)	CFNB Epidural analgesia	No block	Knee flexion at 6 weeks and 3 months
Tammachote 2013 Single	59/57/57 (28/29)	Periarticular infiltration	Intrathecal morphine	ROM at 2, 6 and 12 weeks Modified Thai version of the WOMAC score (at 6 and 12 weeks)
Wu 2014 Unblinded	79/60/60 (30/30)	CFNB	No block	Knee Society Score (difference with preoperative value) at discharge, at 6 weeks, 3 months and 6 months
Zhang 2011 Double	96/80/80 (26/27/27)	Periarticular infiltration Periarticular infiltration then ropivacaine/ketorolac infusion	Saline intra‐articular infusion	Maximum knee flexion after 7 days (early recovery) and 90 days (late recovery)
CFNB: continuous femoral nerve block; POD: postoperative day; RCT: randomized controlled trial; ROM: range of motion; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index. ^aUnblinded: neither participant, nor personnel, nor assessor of long‐term function were blinded; single: only assessor of long‐term function was blinded; double: participant and personnel were blinded, but assessor of long‐term function was not.

Table 1. Overview of included studies

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Table 2. Timeline chart for included studies

Study	Surgical anaesthesia	Group	Analgesia timeline					Analgesic regimen (common to all within‐study groups)
			POD 0	POD 1	POD 2	POD 3	POD 4
Kadic 2009	Spinal	Exp	CFNB			None		IV morphine PCA Diclofenac + paracetamol
		Con	None
Nader 2012	Spinal‐epidural	Exp	CFNB + epidural	CFNB	None			Hydrocodone / paracetamol PRN If needed, extended‐release oxycodone + hydromorphone PRN
		Con	Epidural	None
Singelyn 1998	GA	Exp	Epidural			None		IV morphine PCA IV propacetamol PRN IM piritramide PRN
		Exp	CFNB			None
		Con	IV morphine PCA			None
Tammachote 2013	Spinal	Exp	Periarticular infiltration	None				IV ketorolac PCA until POD 3, then PO naproxen and tramadol PRN PO paracetamol and amitriptyline
		Con	Intrathecal morphine	None
Wu 2014	Spinal	Exp	CFNB			None		Paracetamol + sustained release diclofenac Oral opioids (codeine or morphine) Metoclopramide, senna and famotidine to prevent side effects
		Con	IV morphine PCA			None
Zhang 2011	GA	Exp	Periarticular infiltration	Placebo		None		Celecoxib IV morphine PCA IM morphine PRN
		Exp		Ropivacaine + ketorolac infusion		None
		Con	Placebo			None
CFNB: continuous femoral nerve block; Con: Control; Exp: Experimental; GA: general anaesthesia;IM: intramuscular;IV: intravenous; PCA: patient‐controlled analgesia; POD: postoperative day;PRN: as needed

Table 2. Timeline chart for included studies

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Table 3. Summary of reported results

Study	Outcomes	Results
Study	Outcomes	Control	Experimental	P value^a
Primary total knee replacement
Kadic 2009	Knee flexion at 3 months	110.0 (range 100.0 to120.0)	110.0 (range 110.0 to 112.5)	NS
	Knee Society Score (knee component) at 3 months	83.2 (± 13.2)	83.8 (± 12.8)	0.87
	Knee Society Score (function component) at 3 months	58.5 (± 21.2)	61.2 (± 29.3)	0.70
	WOMAC (pain) at 3 months	80.0 (± 18.7)	83.8 (± 12.9)	0.39
	WOMAC (stiffness) at 3 months	71.3 (± 22.4)	75.6 (± 17.4)	0.44
	WOMAC (function) at 3 months	71.8 (± 19.5)	80.4 (± 10.5)	0.05
Nader 2012^b	Knee flexion at 6 months	124.47 (± 8.32)	123.31 (± 9.53)	0.61
	Knee flexion at 12 months	124.56 (± 7.67)	124.50 (± 10.37)	0.98
	WOMAC at 6 months	11.04 (± 12.50)	14.18 (± 15.70)	0.39
	WOMAC at 12 months	6.76 (± 7.26)	17.39 (± 17.84)	0.003
Singelyn 1998	Knee flexion at 3 months	116 (± 11)	121 (± 12)	0.24
Tammachote 2013	Knee flexion at 3 months	140 (± 4)	139 (± 4)	0.35
Tammachote 2013	WOMAC at 3 months	9 (± 4)	9 (± 4)	1.00
Wu 2014	Knee Society Score (difference with preoperative value) at 3 months	+ 42.87	+ 44.63	0.78
Wu 2014	Knee Society Score (difference with preoperative value) at 6 months	+ 44.7	+ 48.73	0.51
Zhang 2011	Knee flexion at 3 months	105.7 (3.4)	112.2 (3.8)	P value < 0.001
NS: non‐significant; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index. ^aP value calculated using a two‐tailed unpaired t‐test. ^bThe Nader study showed a very significant difference between WOMAC scores at 12 months, while there was no difference at 6 months. The authors concluded that this finding was probably due to confounders such as subsequent surgical procedures: "[P]atients in the CFA [continuous femoral analgesia] group had undergone additional orthopaedic procedures more frequently, which may have impacted the functional recovery and health‐related quality of life following the procedure from this study. A possible explanation for the greater incidence of addition procedures in the CFA group may be due to the greater patient satisfaction scores with their initial surgery."

Table 3. Summary of reported results

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Table 4. Adverse events

Study	Adverse events attributable to the regional anaesthesia technique		Common short‐term adverse events not directly related to regional anaesthesia
Study	Control	Experimental	Event	Experimental	Control	P value^a
Kadic 2009	None	None	PONV	2	13	0.0007
			Drowsiness	0	3	0.11
			Constipation	0	4	0.05
			Urine retention	0	1	0.49
Nader 2012	1 fall (Exp); NS	4 DVTs (Con); P = 0.04 3 positive joint aspirates (Exp); P = 0.08	Nausea	0	0	1.00
			Vomiting	0	0	1.00
			Pruritus	2	1	1.00
Singelyn 1998	6 catheter technical issues (Epidural); P < 0.001 vs. CFNB and IV PCA Falls, LA toxicity, etc.: not reported	Not discussed	PONV	9 (5/4)	6	0.52
			Hypotension	1 (0/1)	0	1.00
			Urine retention	6 (0/6)	2	0.70
Tammachote 2013	Not discussed	No wound problem Other complications not discussed	PONV	10	20	0.02
			Pruritus	3	11	0.03
			Urine retention	0	0	1.00
			Respiratory depression	0	0	1.00
Wu 2014	None	5 DVTS (2 Exp, 3 Con) 5 cases of bleeding requiring transfusion (2 Exp, 3 Con) 5 shocks in ward (3 Exp, 2 Con) 2 wound infections (1 Exp, 1 Con)	PONV	8	19	0.009
			Urine retention	3	8	0.18
			Dizziness	5	12	0.08
			Desaturation	0	1	1.00
			Pruritus	not reported
Zhang 2011	None	6 DVTs (2 Exp1, 2 Exp2, 2 Con): NS	PONV	8 (4/4)	7	0.36
			Pruritus	2 (1/1)	1	1.00
			Urine retention	2 (1/1)	2	0.60
			Respiratory depression	1 (0/1)	1	1.00
Pooled 199 in Exp groups 158 in Control groups	not applicable	not applicable	PONV	37/199	67/158	< 0.0001
			Pruritus	7/169	13/128	0.06
			Urine retention	11/199	13/158	0.40
Con: control group; DVT: deep vein thrombosis; Exp: experimental group; PONV: postoperative nausea and vomiting. ^aP values were calculated using a two‐tailed Fisher’s exact test.

Table 4. Adverse events

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Comparison 1. Functional outcome at 3 months

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Knee flexion Show forest plot	3	140	Mean Difference (IV, Random, 95% CI)	3.99 [‐2.23, 10.21]

2 Knee flexion (Infiltration only) Show forest plot	2	110	Mean Difference (IV, Random, 95% CI)	2.76 [‐4.59, 10.11]

Comparison 1. Functional outcome at 3 months

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