Analgesia regional para mejorar el resultado funcional a largo plazo después del reemplazo electivo de una articulación grande
Referencias
References to studies included in this review
References to studies excluded from this review
References to studies awaiting assessment
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Methods | Partially blinded, randomized, controlled trial Random allocation to a group by drawing a sealed envelope from a pile Follow‐up: 3 months | |
| Participants | Subjects: 58 participants enrolled (53 analysed, 48 followed up to 3 months) from one university hospital: Radboud University Nijmegen Medical Centre in the Netherlands Operation: primary total knee replacement 2 groups (of 27 and 26 people) Mean age (SD): group 1, 67.4 (± 12); group 2, 66.8 (± 11) Sex: group 1, 7 males and 20 females; group 2, 7 males and 19 females | |
| Interventions | Standardized anaesthetic: spinal using 15 mg of 5 mg/mL isobaric bupivacaine
Standard analgesic regimen using paracetamol, diclofenac and a morphine IV PCA (bolus 1 mg, lockout 6 minutes) | |
| Outcomes |
Catheter position was tested immediately after insertion using lidocaine; however, there is no information as to whether any of the blocks needed additional troubleshooting. | |
| Funding source | Not provided | |
| Declarations of interest | None reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "For the randomization procedure, 58 sealed envelopes enclosed a note of either the study or the control group. A blinded operating room nurse drew an envelope, which allocated the patient to one of the groups." |
| Allocation concealment (selection bias) | Low risk | As above: random draw procedure with sealed envelopes |
| Blinding of participants and personnel (performance bias) | Unclear risk | No mention of blinding for participants or personnel assessing participants during their hospital stay |
| Blinding of outcome assessment (detection bias) | Low risk | "The knee function was assessed by a blinded, independent physician, 3 months after surgery at the orthopaedic outpatient centre." |
| Incomplete outcome data (attrition bias) | Low risk | "[F]ive patients were excluded from the analysis due to protocol violations (one study, two control), a severe adverse reaction to morphine (one control) and for not meeting the inclusion criteria (one study)." At the 3‐month assessment, data from only 48 patients are given (21 in the study group, and 17 in the control group), but no explanation is given as to why 5 more patients were lost to follow‐up. |
| Selective reporting (reporting bias) | Low risk | Knee Score and WOMAC components reported as mean and SD |
| Methods | Unblinded, randomized, controlled trial Computer‐generated random allocation sequence Follow‐up: 12 months | |
| Participants | Subjects: 62 participants enrolled (60 followed up to 12 months) from one university hospital: Northwestern University, Chicago, IL Operation: primary total knee replacement 2 groups (of 31 people each) Age: group 1, 65 (IQR 60 to 76); group 2, 64 (IQR 60 to 71) Sex: group 1, 13 males and 18 females; group 2, 7 males and 24 females | |
| Interventions | All participants received spinal‐epidural anaesthesia (10 mg of 5 mg/mL isobaric bupivacaine intrathecally, epidural test dose 3 mL of 15 mg/mL lidocaine with 1:200,000 epinephrine) followed by epidural analgesia (continuous infusion of 3 mL/h of 1mg/mL bupivacaine with hydromorphone 10 mcg/mL, patient boluses of 3 mL with a lockout time of 15 minutes and an hourly maximum of 15 mL) until the morning of POD 1
No adjuvants Oral postoperative analgesic regimen in both groups: hydrocodone 10 mg plus paracetamol 325 mg every 4 to 6 hours for pain as needed; if participants could not achieve a VRSP < 4, the analgesic regimen was changed to sustained release oxycodone 10 mg every 12 hours plus oral hydromorphone 2 mg every 4 hours for breakthrough pain; not different between groups | |
| Outcomes | Primary outcome: knee flexion at 1, 6 and 12 months Secondary outcomes: patient satisfaction during hospital stay, amount of opioid analgesic consumed, verbal rating of pain during hospital stay and follow‐up visits, health‐related quality of life, and functional outcome on POD 1, POD 2, POD 3, and at 1 month, 6 months, and 12 months after surgery Effectiveness of the regional analgesia is not reported | |
| Funding source | Stryker Instruments, Inc. and departmental funds | |
| Declarations of interest | None reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was determined using a computer‐generated random allocation sequence" |
| Allocation concealment (selection bias) | Low risk | "[G]roup membership was concealed by placing the assignment slip in an opaque envelope that was not opened until after informed consent was obtained." |
| Blinding of participants and personnel (performance bias) | High risk | No blinding. Participants in the CFA group received a femoral perineural catheter while participants in the OOA group did not. |
| Blinding of outcome assessment (detection bias) | Unclear risk | No blinding. This is not explicitly stated, but it is possible that the investigators and the surgeon assessing the participants had access to the records that would show whether each participant had received a continuous femoral block. |
| Incomplete outcome data (attrition bias) | Low risk | Only 1 participant in each group lost to follow‐up after 1 month |
| Selective reporting (reporting bias) | Unclear risk | The difference in knee flexion on POD 3 and at 1 month is significant but only reported graphically, with no values given. While the components of the WOMAC score are reported as median (range), the scores themselves are not reported. |
| Methods | Unblinded, randomized, controlled trial Computer‐generated list of random permutations Follow‐up: 3 months | |
| Participants | Subjects: 45 participants enrolled (not stated how many followed‐up to 3 months) from one university hospital: St. Luc Hospital in Brussels, Belgium Operation: primary total knee replacement 3 groups (of 15 people each) Age and sex distribution not provided: "Population data (age, weight, height, gender ratio) were comparable in all groups." | |
| Interventions | Standardized general anaesthesia for surgical procedure Analgesia for the first 48 hours:
In all groups, if VAS ≥ 1, 1 g of propacetamol was given. In groups 2 and 3, if VAS was unchanged after 30 min, 10 to 20 mg of IM piritramide and an opioid mu‐agonist were given | |
| Outcomes |
| |
| Funding source | Not provided | |
| Declarations of interest | None reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated list of random permutations; no detail as to whether the list was exposed or concealed |
| Allocation concealment (selection bias) | Unclear risk | Concealment technique not stated |
| Blinding of participants and personnel (performance bias) | High risk | No blinding mentioned; observers could easily see whether the participant had an epidural catheter, a femoral catheter, or none |
| Blinding of outcome assessment (detection bias) | Unclear risk | No blinding mentioned; observers could refer to the chart to know what type of analgesia the participant had received |
| Incomplete outcome data (attrition bias) | Unclear risk | Tables suggest that no participant was lost to follow‐up, but that is not clearly stated. |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Methods | Partially blinded, randomized, controlled trial Computerized block randomization; sealed opaque envelopes Follow‐up: 12 weeks | |
| Participants | Subjects: 59 participants enrolled (57 analysed and followed up to 12 weeks) from one university hospital: Thammasat University, Pathumthani, Thailand Operation: primary total knee replacement 2 groups (of 28 and 29 people) Mean age (SD): control group, 69 (± 8); experimental group, 70 (± 7) Sex: control group, 8 males and 20 females; experimental group, 3 males and 26 females | |
| Interventions | Spinal anaesthesia using 2.5 mL of 5 mg/mL isobaric bupivacaine
100 mg bupivacaine (5 mg/mL, 20 mL), 5 mg morphine sulphate (5 mL), 0.6 mg epinephrine (0.6 mL), 30 mg ketorolac tromethamine (1 mL), and 73.4 mL saline (total volume: 100 mL). The first 25 mL were injected into the posterior knee capsule and soft tissue around the medial and lateral collateral ligaments before implantation. Quadriceps muscle, retinacular tissues, pes anserinus, and suprapatellar and infrapatellar fat pad, then infiltrated with the rest of the mixture. Postoperative analgesia:
| |
| Outcomes | Primary outcomes:
Secondary outcomes:
| |
| Funding source | Not provided | |
| Declarations of interest | None reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Computerized block randomization was done by an independent research assistant (TY) who otherwise was not engaged in the study. The anaesthesiologist assistant nurse, who opened sealed opaque envelopes containing the randomization result, allocated patients into each group." |
| Allocation concealment (selection bias) | Low risk | "The anaesthesiologist assistant nurse, who opened sealed opaque envelopes containing the randomization result, allocated patients into each group." |
| Blinding of participants and personnel (performance bias) | Unclear risk | Personnel was not blinded. It is unclear whether participants were blinded or aware of their group assignment. |
| Blinding of outcome assessment (detection bias) | Unclear risk | "A clinical investigator (SK) who was not aware of the randomization collected demographic data, preoperative clinical conditions using predesigned data sheets, and perioperative data, and entered them in a database." However, there is no mention of blinding of the assessor of the long‐term outcome. |
| Incomplete outcome data (attrition bias) | Low risk | "Two knees were excluded from analysis because one had drain dislodgement before 48 hours and the other had a periprosthetic fracture (Lewis and Rorabeck Type 2) from an accident 6 weeks after surgery." |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
| Methods | Unblinded, randomized, controlled trial Computer‐generated random sequence, sealed opaque envelopes Follow‐up: 6 months | |
| Participants | Subjects: 79 participants enrolled (60 followed up to 6 months) from one hospital: Yan Chai Hospital, Hong Kong, China Operation: primary total knee replacement 2 groups (of 30 people each); 19 others excluded for various reasons before or after entering the study Mean age (SD): group 1, 68.9 (± 7.5); group 2, 68.8 (± 6.4) Sex: group 1, 8 males and 22 females; group 2, 8 males and 22 females | |
| Interventions | Spinal anaesthesia (incompletely standardized: 58 participants received hyperbaric bupivacaine, one received levobupivacaine, and one isobaric bupivacaine; the volume also varied: 2.5 ± 0.3 mL in one group and 2.6 ± 0.3 mL in the other) Identical standardized multimodal analgesic regimen (if not contraindicated) including paracetamol, sustained release diclofenac, opioids (codeine or morphine), and drugs to prevent the side effects of the NSAIDs and opioids. Unclear how many surgeons performed the procedures.
Participants were not mobilized until POD 1 | |
| Outcomes |
| |
| Funding source | Not provided | |
| Declarations of interest | None reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “These 60 patients were randomized to the CFNB and PCA groups (30 patients in each), using computer‐generated random numbers. Subjects were divided into two groups (odd against even numbers generated by the computer)." |
| Allocation concealment (selection bias) | Low risk | "The case allocation was concealed in sealed envelopes and the mode of analgesia revealed to case anaesthetist and patient after the patient was included in the study.” |
| Blinding of participants and personnel (performance bias) | High risk | No blinding |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not stated whether the outcome assessor was blinded to group allocation |
| Incomplete outcome data (attrition bias) | High risk | "In all, 79 patients were recruited but 19 were excluded for various reasons . . . [R]eplacements were recruited using the permuted block technique." Some patients were excluded after entering the study for reasons such as failed spinal, infusion stopped, catheter dislodged, manpower limits, etc. |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported, except for the Timed Up and Go test because of missing data |
| Methods | Unblinded, randomized, controlled trial Computer‐generated random sequence, sealed opaque envelopes Follow‐up: 3 months | |
| Participants | Subjects: 96 participants enrolled (80 followed‐up to 3 months) from one hospital: Affiliated Hospital of Ningxia Medical University, Yinchuan, China Operation: primary total knee replacement 3 groups (initial size 32 each; for analysis, groups of 26, 27 and 27) Mean age (SD): group 1, 68 (± 9); group 2, 66 (± 8); group 3, 68 (± 9) Sex: group 1, 12 males and 14 females; group 2, 13 males and 14 females; group 3, 13 males and 14 females | |
| Interventions | General anaesthesia by the same anaesthetist (unclear whether standardized) Celecoxib 200 mg orally the night before surgery, and twice daily on PODs 1 through 7 All surgeries performed by the same surgeon Before joint closure, an intra‐articular epidural 18G catheter was inserted, with the catheter tip running along the medial femoral condyle, usually on raw bone, medial to the metal femoral component
*Infiltration: "[A] mixture of ropivacaine 150 ml (2 mg/mL) and ketorolac 1 mL (30 mg/mL) was prepared. Of this, 50 mL was loaded into a 50‐mL syringe and used to infiltrate the skin and subcutaneous tissues in equal proportions along the whole length of the wound. The remaining 101 mL had adrenaline 0.5 mL (1 mg/mL) added, giving a total volume of 102 mL and was loaded into two further 50‐mL syringes, which were used to infiltrate below the deep tissues around the ligaments, the capsule incision and the synovium." A compression bandage and ice packs were applied around the knee joint during the first postoperative day Morphine IV PCA with 1 mg bolus and 6 min lockout but maximal 1‐hour dose of 5 mg, for 48 hours If pain remained 'intolerable', an extra dose of morphine between 5 and 10 mg was injected intramuscularly (and repeated if necessary) until a pain score of ≤ 3 was obtained | |
| Outcomes |
| |
| Funding source | Not provided | |
| Declarations of interest | No conflict of interest reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The patients were divided randomly into three groups (CLIA, SLIA and controls), by a biostatistician blinded to the nature of the study, using a computer‐generated random sequence concealed in consecutively numbered opaque sealed envelopes." |
| Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes were used to conceal group allocation. "Assessment of patients for inclusion and preparation of the drug treatments were performed by an investigator not otherwise involved in data collection." |
| Blinding of participants and personnel (performance bias) | Low risk | "Assessment of patients for inclusion and preparation of the drug treatments were performed by an investigator not otherwise involved in data collection. Injection of the drug treatments and the recording of postoperative data were performed by another investigator who was blinded to the study groups." All participants had a catheter in place. |
| Blinding of outcome assessment (detection bias) | Unclear risk | "Postoperative knee pain was evaluated by specially trained pain nurses, who were not involved in the patients’ treatment." It is unclear, however, whether those nurses were blinded to the participant's group allocation. No description of blinding for functional recovery evaluation |
| Incomplete outcome data (attrition bias) | Low risk |
|
| Selective reporting (reporting bias) | Low risk | All stated outcomes are reported in a detailed fashion |
CFA: continuous femoral analgesia; CFNB: continuous femoral nerve block; CLIA: continuous local infiltration analgesia; DVT: deep vein thrombosis; IQR: inter‐quartile range; IM: intramuscular;IV: intravenous POD: post‐operative day; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index; OOA: Oral opioid analgesia; PCA: intravenous patient‐controlled analgesia; PO: orally; SD: standard deviation; SLIA: single‐injection local infiltration analgesia; VAS: visual analogue scale (for pain); VRSP: verbal rating score for pain.
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Comparison of two regional techniques with no control group; insufficient follow‐up | |
| Insufficient follow‐up (2 days) | |
| Insufficient follow‐up (24 hours) | |
| Insufficient follow‐up (48 hours) | |
| Comparison of two regional techniques | |
| Insufficient follow‐up (24 hours) | |
| Insufficient follow‐up (24 hours) | |
| Insufficient follow‐up (24 hours) | |
| Insufficient follow‐up (72 hours) | |
| The study included participants who underwent both total knee replacement and knee ligament reconstruction. Despite several requests, we could not obtain the original data to use only the results of the participants having undergone a TKR | |
| Abstract only. Results could not be obtained from the authors | |
| Insufficient follow‐up (5 days) | |
| Insufficient follow‐up (24 hours) | |
| Abstract only. Insufficient follow‐up (48 hours) | |
| Insufficient follow‐up (3 days) | |
| Insufficient follow‐up (48 hours) | |
| All participants received regional analgesia for the first 24 hours, and were then administered placebo or local anaesthetic depending on their group assignment. Thus, there was no real comparison of regional analgesia vs. non‐regional analgesia. | |
| All participants received regional analgesia for the first 24 hours, and were then administered placebo or local anaesthetic depending on their group assignment. Thus, there was no real comparison of regional analgesia vs. non‐regional analgesia. | |
| Insufficient follow‐up (32 hours) | |
| Letter to the editor commenting on Allen 1998b | |
| Insufficient follow‐up (48 hours) | |
| Insufficient follow‐up (6 weeks). Abstract only | |
| Insufficient follow‐up (48 hours) | |
| Abstract only, not published as article. Follow‐up of 48 hours, therefore data was not sought out. | |
| Insufficient follow‐up (48 hours) | |
| Comparison of two regional techniques; insufficient follow‐up | |
| Not a regional analgesia technique | |
| Unable to obtain article; however, from abstract, comparison of 2 regional techniques and insufficient follow‐up (24 hours) | |
| Insufficient follow‐up (48 hours); participants undergoing surgery for hip fracture rather than elective joint replacement | |
| Comparison of intra‐articular infusion of local anaesthetic vs. epidural plus femoral nerve block. Insufficient follow‐up (24 hours) | |
| Non‐randomized; 48‐hour follow‐up | |
| Insufficient follow‐up (48 hours) | |
| Insufficient follow‐up (24 hours) | |
| Insufficient follow‐up (48 hours) | |
| Abstract only; retrospective review | |
| Insufficient follow‐up (48 hours) | |
| Insufficient follow‐up (48 hours) | |
| Insufficient follow‐up (until discharge) | |
| Intra‐articular infusion of local anaesthetic at a low rate (2 mL/h), insufficient to affect postoperative pain scores or morphine use | |
| For patients in the total knee replacement group, the comparison was between two regional techniques. Range‐of‐motion data was collected but not published. For patients in the total hip replacement group, only pain and quality‐of‐life data were collected. |
Characteristics of studies awaiting assessment [ordered by study ID]
| Methods | Partially blinded, randomized, controlled trial "Eligible patients were randomly assigned to treatment groups in blocks of different sizes (4, 6, and 8), according to a list pre‐prepared by the study epidemiologist (AV)." Follow‐up: 1 year (follow‐up of a subset of participants from a previously published study) |
| Participants | Subjects: 60 participants enrolled (27 analysed and followed‐up to one year) from one university hospital: Jewish General Hospital, McGill University, Montreal, Canada Operation: primary total knee replacement 3 groups (of 19, 20 and 20 people, with one participant excluded after randomization because of postoperative confusion) Age: femoral group, 65.1 (SEM 2.0); obturator group, 72 (SEM 1.8); control group, 67 (SEM 1.3) Sex: femoral group, 4 males and 15 females; obturator group, 4 males and 16 females; control group, 5 males and 15 females |
| Interventions |
|
| Outcomes |
|
| Notes | Unclear which participants were followed‐up until 1 year. More than 50% lost to follow‐up. Assessor and participant blinded, but anaesthesiologist unblinded. |
HSS: hospital for special surgery;IM: intramuscular; IV: intravenous; L2 ‐L5: lumbar; PACU: post anaesthesia care unit; PCA: patient‐controlled analgesia; POD: postoperative day; SEM: standard error of the mean
Data and analyses
| 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] |
| Analysis 1.1  Comparison 1 Functional outcome at 3 months, Outcome 1 Knee flexion. | ||||
| 2 Knee flexion (Infiltration only) Show forest plot | 2 | 110 | Mean Difference (IV, Random, 95% CI) | 2.76 [‐4.59, 10.11] |
| Analysis 1.2  Comparison 1 Functional outcome at 3 months, Outcome 2 Knee flexion (Infiltration only). | ||||
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Functional outcome at 3 months, Outcome 1 Knee flexion.
Comparison 1 Functional outcome at 3 months, Outcome 2 Knee flexion (Infiltration only).
| 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 | No. of Participants | Quality of the evidence | |
| 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 | ⊕⊝⊝⊝ |
| 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 | ⊕⊝⊝⊝ |
| *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). | |||||
| GRADE Working Group grades of evidence | |||||
| aUnclear risk of detection bias (unclear outcome observer blinding), especially as pain is a subjective assessment. | |||||
| Regional anaesthesia compared to conventional pain control for total knee replacement patients | ||||
| Patient or population: total knee replacement patients | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No. of Participants | Quality of the evidence | |
| Assumed risk | Corresponding risk | |||
| Conventional pain control | Regional Analgesia | |||
| Knee flexion | The mean knee flexion ranged across control groups from | The mean knee flexion in the intervention groups was | 140 | ⊕⊝⊝⊝ |
| *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). | ||||
| GRADE Working Group grades of evidence | ||||
| aHigh or unclear risk of detection bias (unclear outcome observer blinding), especially as pain is a subjective assessment. | ||||
| Study Blindinga | Population: Enrolled/analysed/followed up to at least 3 months (no. per group) | Intervention(s) | Control | Postoperative outcomes |
| 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) |
| 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 |
| Unblinded | 45/45/45 (15/15/15) | CFNB Epidural analgesia | No block | Knee flexion at 6 weeks and 3 months |
| 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) |
| 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 |
| 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. | ||||
| Study | Surgical anaesthesia | Group | Analgesia timeline | Analgesic regimen (common to all within‐study groups) | ||||
| POD 0 | POD 1 | POD 2 | POD 3 | POD 4 | ||||
| Spinal | Exp | CFNB | None | IV morphine PCA Diclofenac + paracetamol | ||||
| Con | None | |||||||
| Spinal‐epidural | Exp | CFNB + epidural | CFNB | None | Hydrocodone / paracetamol PRN If needed, extended‐release oxycodone + hydromorphone PRN | |||
| Con | Epidural | None | ||||||
| GA | Exp | Epidural | None | IV morphine PCA IV propacetamol PRN IM piritramide PRN | ||||
| Exp | CFNB | None | ||||||
| Con | IV morphine PCA | None | ||||||
| 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 | ||||||
| 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 | ||||||
| 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 | ||||||||
| Study | Outcomes | Results | ||
| Control | Experimental | P valuea | ||
| Primary total knee replacement | ||||
| 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 | |
| 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 | |
| Knee flexion at 3 months | 116 (± 11) | 121 (± 12) | 0.24 | |
| Knee flexion at 3 months | 140 (± 4) | 139 (± 4) | 0.35 | |
| WOMAC at 3 months | 9 (± 4) | 9 (± 4) | 1.00 | |
| Knee Society Score (difference with preoperative value) at 3 months | + 42.87 | + 44.63 | 0.78 | |
| Knee Society Score (difference with preoperative value) at 6 months | + 44.7 | + 48.73 | 0.51 | |
| 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. | ||||
| Study | Adverse events attributable to the regional anaesthesia technique | Common short‐term adverse events not directly related to regional anaesthesia | ||||
| Control | Experimental | Event | Experimental | Control | P valuea | |
| None | None | PONV | 2 | 13 | 0.0007 | |
| Drowsiness | 0 | 3 | 0.11 | |||
| Constipation | 0 | 4 | 0.05 | |||
| Urine retention | 0 | 1 | 0.49 | |||
| 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 | |||
| 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 | |||
| 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 | |||
| 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 | |||||
| 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. | ||||||
| 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] |
