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Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial.

ABSTRACT: BACKGROUND:Previously, we have demonstrated that extending a continuous femoral nerve block (cFNB) from overnight to 4 days after total knee arthroplasty (TKA) provides clear benefits during the infusion, but not subsequent to catheter removal. However, there were major limitations in generalizing the results of that investigation, and we subsequently performed a very similar study using a multicenter format, with many health care providers, in patients on general orthopedic wards, thus greatly improving inference of the results to the general population. Not surprisingly, the perioperative/short-term outcomes differed greatly from the first, more limited study. We now present a prospective follow-up study of the previously published, multicenter, randomized controlled clinical trial to investigate the possibility that an extended ambulatory cFNB decreases long-term pain, stiffness, and functional disability after TKA, which greatly improves inference of the results to the general population. METHODS:Subjects undergoing TKA received a cFNB with ropivacaine 0.2% from surgery until the following morning, at which time patients were randomized to continue either perineural ropivacaine (n=28) or normal saline (n=26). Patients were discharged with their catheter and a portable infusion pump, and catheters were removed on postoperative day 4. Health-related quality of life was measured using the Western Ontario and McMaster Universities Osteoarthritis Index preoperatively and then at 7 days, as well as 1, 2, 3, 6, and 12 months after surgery. This index evaluates pain, stiffness, and physical functional disability. For inclusion in the analysis, we required a minimum of 4 of the 6 time points, including day 7 and at least 2 of months 3, 6, and 12. RESULTS:The 2 treatment groups had similar Western Ontario and McMaster Universities Osteoarthritis scores for the mean area-under-the-curve calculations (point estimate for the difference in mean area under the curve for the 2 groups [overnight infusion group - extended infusion group]=3.8; 95% confidence interval, -3.8 to +11.3; P=0.32) and at all individual time points (P>0.05). CONCLUSIONS:This investigation found no evidence that extending an overnight cFNB to 4 days improves (or worsens) subsequent pain, stiffness, or physical function after TKA in patients of multiple centers convalescing on general orthopedic wards.

SUBMITTER: Ilfeld BM

PROVIDER: S-EPMC3073537 | biostudies-literature | 2011 Mar-Apr

REPOSITORIES: biostudies-literature

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Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial.

Ilfeld Brian M BM Shuster Jonathan J JJ Theriaque Douglas W DW Mariano Edward R ER Girard Paul J PJ Loland Vanessa J VJ Meyer Scott S Donovan John F JF Pugh George A GA Le Linda T LT Sessler Daniel I DI Ball Scott T ST

Regional anesthesia and pain medicine 20110301 2

<h4>Background</h4>Previously, we have demonstrated that extending a continuous femoral nerve block (cFNB) from overnight to 4 days after total knee arthroplasty (TKA) provides clear benefits during the infusion, but not subsequent to catheter removal. However, there were major limitations in generalizing the results of that investigation, and we subsequently performed a very similar study using a multicenter format, with many health care providers, in patients on general orthopedic wards, thus ...[more]

PMID: 21425510

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Project description:The ideal local anesthetic regime for femoral nerve block that balances analgesia with mobility after total knee arthroplasty (TKA) remains undefined.We compared two volumes and concentrations of a fixed dose of ropivacaine for continuous femoral nerve block after TKA to a single injection femoral nerve block with ropivacaine to determine (1) time to discharge readiness; (2) early pain scores and analgesic consumption; and (3) functional outcomes, including range of motion and WOMAC scores at the time of recovery.Ninety-nine patients were allocated to one of three continuous femoral nerve block groups for this randomized, placebo-controlled, double-blind trial: a high concentration group (ropivacaine 0.2% infusion), a low concentration group (ropivacaine 0.1% infusion), or a placebo infusion group (saline 0.9% infusion). Infusions were discontinued on postoperative Day (POD) 2. The primary outcome was time to discharge readiness. Secondary outcomes included opioid consumption, pain, and functional outcomes. Ninety-three patients completed the study protocol; the study was halted early because of unanticipated changes to pain protocols at the host institution, by which time only 61% of the required number of patients had been enrolled.With the numbers available, the mean time to discharge readiness was not different between groups (high concentration group, 62 hours [95% confidence interval [CI], 51-72 hours]; low concentration group, 73 hours [95% CI, 63-83 hours]; placebo infusion group 65 hours [95% CI, 56-75 hours]; p = 0.27). Patients in the low concentration group consumed significantly less morphine during the period of infusion (POD 1, high concentration group, 56 mg [95% CI, 42-70 mg]; low concentration group, 35 mg [95% CI, 27-43 mg]; placebo infusion group, 48 mg [95% CI, 38-59 mg], p = 0.02; POD 2, high concentration group, 50 mg [95% CI, 41-60 mg]; low concentration group, 33 mg [95% CI, 24-42 mg]; placebo infusion group, 39 mg [95% CI, 30-48 mg], p = 0.04); however, there were no important differences in pain scores or opioid-related side effects with the numbers available. Likewise, there were no important differences in functional outcomes between groups.Based on this study, which was terminated prematurely before the desired sample size could be achieved, we were unable to demonstrate that varying the concentration and volume of a fixed-dose ropivacaine infusion for continuous femoral nerve block influences time to discharge readiness when compared with a conventional single-injection femoral nerve block after TKA. A low concentration of ropivacaine infusion can reduce postoperative opioid consumption but without any important differences in pain scores, side effects, or functional outcomes. These pilot data may be used to inform the statistical power of future randomized trials.Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Project description:Unsatisfactory analgesia for major knee surgery with femoral nerve block (FNB) alone was reported and the additional benefit of sciatic block to continuous femoral nerve block (CFNB) was not conclusive. The aim of the present study was to find the benefit of the additional mini-dose spinal morphine (0.035 mg) to CFNB for postoperative pain control and to compare their associated side effects after total knee arthroplasty (TKA).After written informed consent and with Institutional Ethics Committee approval, 68 American Society of Anesthesiologists (ASA) Physical Status I-III patients scheduled for elective unilateral TKA under spinal anesthesia (SA) were included in the present prospective, randomized controlled study. The patients were allocated into two groups. CFNB was placed in all patients by the inguinal paravascular approach with 20 ml of 0.25 % levobupivacaine. Group I (named CFNB/SA group), SA was administered with 2.8 ml levobupivacaine and Group II (named CFNB/SAMO group), SA with 2.8 ml levobupivacaine plus morphine 0.035 mg. At Post Anesthesia Care Unit (PACU), pain and other adverse effects were recorded. Pain was assessed by visual analog scale (VAS) 0-10. Tramadol 50 mg intravenous (IV) was given if the VAS > 4. In the ward, all patients were maintained by continuous femoral infusion of 0.125 % levobupivacaine rate 7 ml/hr and then reduced to 5 ml/hr if VAS ≤3.Patient's demographics data in each group were not different. At post-operative (PO) 12-24 h, the VAS scores were significantly lesser in the CFNB/SAMO group. Cumulative tramadol IV requirement for PO48h were also significantly lesser in the CFNB/SAMO group. Nausea, vomiting and numbness were significantly greater in the CFNB/SAMO group during early postoperative period (PO1-6 h).Though in some patients CFNB was inadequate, a mini-dose of intrathecal morphine (0.035 mg) in addition to CFNB was found to be effective with minimal side effects.Thai Clinical Trial Registry (identifier: TCTR20150609003 , date of registration: 6 June 2015).

Project description:BACKGROUND:Multiorifice catheters have been shown to provide superior analgesia and significantly reduce local anesthetic consumption compared with end-hole catheters in epidural studies. This prospective, blinded, randomized study tested the hypothesis that, in continuous femoral nerve block (CFNB) under ultrasound guidance, multiorifice catheter would reduce local anesthetic consumption at 24?h compared with end-hole catheter. METHODS:Eighty adult patients (aged ?18?years) scheduled to undergo primary total knee arthroplasty under a combination of CFNB, sciatic nerve block and general anesthesia were randomized to CFNB using either a 3-pair micro-hole (Contiplex, BRAUN®, 20G - 400?mm) or an end-hole (Silverstim VYGON®, 20G - 500?mm) catheter. Once the femoral catheter was sited, a bolus of 20?mL lidocaine 1% was injected. An electronic pump then delivered an automated 5?mL bolus of ropivacaine 0.2% hourly, with 10?mL self-administered patient controlled analgesia boluses. RESULTS:There was no inter-group difference in either median number of ropivacaine boluses on demand during the first 24?h (4(2-7) vs. 4(2-8) in six-hole and end-hole groups, respectively; P?=?0.832) or median ropivacaine consumption at 48?h (365(295-418) vs. 387(323-466); P?=?0.452). No significant differences were recorded between the groups at 24?h regarding median average verbal rate pain scale (2(0-3) vs. 2(0-4); P?=?0.486) or morphine consumption (0(0-20) vs. 0(0-20); P?=?0.749). Quadriceps muscle strength declined to 7% (0-20) and 10% (0-28) in the six-hole and end-hole groups, respectively, at 24?h after surgery (P?=?0.733). CONCLUSIONS:In this superiority trial, catheter orifice configuration did not influence the effectiveness of CFNB in this setting: quality of analgesia was similar, with no reduction in either local anesthetic or morphine consumption, and equivalent postoperative quadriceps weakness. TRIAL REGISTRATION:Retrospectively registered at ( NCT03376178 ). Date: 21 November 2017.

Dataset Information

Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial.

Publications

Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial.

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