Dataset Information

A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge-readiness following total knee arthroplasty in patients on general orthopaedic wards.

ABSTRACT: A continuous femoral nerve block (cFNB) involves the percutaneous insertion of a catheter adjacent to the femoral nerve, followed by a local anesthetic infusion, improving analgesia following total knee arthroplasty (TKA). Portable infusion pumps allow infusion continuation following hospital discharge, raising the possibility of decreasing hospitalization duration. We therefore used a multicenter, randomized, triple-masked, placebo-controlled study design to test the primary hypothesis that a 4-day ambulatory cFNB decreases the time until each of three predefined readiness-for-discharge criteria (adequate analgesia, independence from intravenous opioids, and ambulation 30m) are met following TKA compared with an overnight inpatient-only cFNB. Preoperatively, all patients received a cFNB with perineural ropivacaine 0.2% from surgery until the following morning, at which time they were randomized to either continue perineural ropivacaine (n=39) or switch to normal saline (n=38). Patients were discharged with their cFNB and portable infusion pump as early as postoperative day 3. Patients who were given 4 days of perineural ropivacaine attained all three criteria in a median (25th-75th percentiles) of 47 (29-69)h, compared with 62 (45-79)h for those of the control group (Estimated ratio=0.80, 95% confidence interval: 0.66-1.00; p=0.028). Compared with controls, patients randomized to ropivacaine met the discharge criterion for analgesia in 20 (0-38) versus 38 (15-64)h (p=0.009), and intravenous opioid independence in 21 (0-37) versus 33 (11-50)h (p=0.061). We conclude that a 4-day ambulatory cFNB decreases the time to reach three important discharge criteria by an estimated 20% following TKA compared with an overnight cFNB, primarily by improving analgesia.

SUBMITTER: Ilfeld BM

PROVIDER: S-EPMC2921457 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge-readiness following total knee arthroplasty in patients on general orthopaedic wards.

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

Pain 20100622 3

A continuous femoral nerve block (cFNB) involves the percutaneous insertion of a catheter adjacent to the femoral nerve, followed by a local anesthetic infusion, improving analgesia following total knee arthroplasty (TKA). Portable infusion pumps allow infusion continuation following hospital discharge, raising the possibility of decreasing hospitalization duration. We therefore used a multicenter, randomized, triple-masked, placebo-controlled study design to test the primary hypothesis that a 4 ...[more]

PMID: 20573448

Similar Datasets

Project description:BACKGROUND:We aimed to determine with this randomized, triple-masked, placebo-controlled study if benefits are afforded by adding a multiple-day, ambulatory, continuous ropivacaine paravertebral nerve block to a single-injection ropivacaine paravertebral block after mastectomy. METHODS:Preoperatively, 60 subjects undergoing unilateral (n = 24) or bilateral (n = 36) mastectomy received either unilateral or bilateral paravertebral perineural catheter(s), respectively, inserted between the third and fourth thoracic transverse process(es). All subjects received an initial bolus of ropivacaine 0.5% (15 mL) via the catheter(s). Subjects were randomized to receive either perineural ropivacaine 0.4% or normal saline using portable infusion pump(s) [5 mL/h basal; 300 mL reservoir(s)]. Subjects remained hospitalized for at least 1 night and were subsequently discharged home where the catheter(s) were removed on postoperative day (POD) 3. Subjects were contacted by telephone on PODs 1, 4, 8, and 28. The primary end point was average pain (scale, 0-10) queried on POD 1. RESULTS:Average pain queried on POD 1 for subjects receiving perineural ropivacaine (n = 30) was a median (interquartile) of 2 (0-3), compared with 4 (1-5) for subjects receiving saline (n = 30; 95% confidence interval difference in medians, -4.0 to -0.3; P = 0.021]. During this same period, subjects receiving ropivacaine experienced a lower severity of breakthrough pain (5 [3-6] vs 7 [5-8]; P = 0.046) as well. As a result, subjects receiving perineural ropivacaine experienced less pain-induced physical and emotional dysfunction, as measured with the Brief Pain Inventory (lower score = less dysfunction): 14 (4-37) versus 57 (8-67) for subjects receiving perineural saline (P = 0.012). For the subscale that measures the degree of interference of pain on 7 domains, such as general activity and relationships, subjects receiving perineural saline reported a median score 10 times higher (more dysfunction) than those receiving ropivacaine (3 [0-24] vs 33 [0-44]; P = 0.035). In contrast, after infusion discontinuation, there were no statistically significant differences detected between treatment groups. CONCLUSIONS:After mastectomy, adding a multiple-day, ambulatory, continuous ropivacaine infusion to a single-injection ropivacaine paravertebral nerve block results in improved analgesia and less functional deficit during the infusion. However, no benefits were identified after infusion discontinuation.

Project description:Hip arthroplasty frequently requires potent postoperative analgesia, often provided with an epidural or posterior lumbar plexus local anesthetic infusion. However, American Society of Regional Anesthesia guidelines now recommend against epidural and continuous posterior lumbar plexus blocks during administration of various perioperative anticoagulants often administered after hip arthroplasty. A continuous femoral nerve block is a possible analgesic alternative, but whether it provides comparable analgesia to a continuous posterior lumbar plexus block after hip arthroplasty remains unclear. We therefore tested the hypothesis that differing the catheter insertion site (femoral versus posterior lumbar plexus) after hip arthroplasty has no impact on postoperative analgesia.Preoperatively, subjects undergoing hip arthroplasty were randomly assigned to receive either a femoral or a posterior lumbar plexus stimulating catheter inserted 5 to 15 cm or 0 to 1 cm past the needle tip, respectively. Postoperatively, patients received perineural ropivacaine, 0.2% (basal 6 mL/hr, bolus 4 mL, 30-minute lockout) for at least 2 days. The primary end point was the average daily pain scores as measured with a numeric rating scale (0-10) recorded in the 24-hour period beginning at 07:30 the morning after surgery, excluding twice-daily physical therapy sessions. Secondary end points included pain during physical therapy, ambulatory distance, and supplemental analgesic requirements during the same 24-hour period, as well as satisfaction with analgesia during hospitalization.The mean (SD) pain scores for subjects receiving a femoral infusion (n = 25) were 3.6 (1.8) versus 3.5 (1.8) for patients receiving a posterior lumbar plexus infusion (n = 22), resulting in a group difference of 0.1 (95% confidence interval -0.9 to 1.2; P = 0.78). Because the confidence interval was within a prespecified -1.6 to 1.6 range, we conclude that the effect of the 2 analgesic techniques on postoperative pain was equivalent. Similarly, we detected no differences between the 2 treatments with respect to the secondary end points, with one exception: subjects with a femoral catheter ambulated a median (10th-90th percentiles) 2 (0-17) m the morning after surgery, in comparison with 11 (0-31) m for subjects with a posterior lumbar plexus catheter (data nonparametric; P = 0.02).After hip arthroplasty, a continuous femoral nerve block is an acceptable analgesic alternative to a continuous posterior lumbar plexus block when using a stimulating perineural catheter. However, early ambulatory ability suffers with a femoral infusion.

Project description:BackgroundPreviously, 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.MethodsSubjects 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.ResultsThe 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).ConclusionsThis 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.

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.

Dataset Information

A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge-readiness following total knee arthroplasty in patients on general orthopaedic wards.

Publications

A multicenter, randomized, triple-masked, placebo-controlled trial of the effect of ambulatory continuous femoral nerve blocks on discharge-readiness following total knee arthroplasty in patients on general orthopaedic wards.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets