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Clinical Trials/NCT02777749
NCT02777749
Completed
Phase 4

Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty

Columbia University1 site in 1 country155 target enrollmentJuly 19, 2016
ConditionsOsteoarthritis
InterventionsBupivacaine

Overview

Phase
Phase 4
Intervention
Bupivacaine
Conditions
Osteoarthritis
Sponsor
Columbia University
Enrollment
155
Locations
1
Primary Endpoint
Change in VAS Pain Scores
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The objective of the study is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty. This randomized clinical trial will compare outcomes between adductor canal blocks, periarticular bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this study will help determine the most appropriate perioperative pain management strategy for patients undergoing a total knee arthroplasty.

Detailed Description

Over 600,000 total knee arthroplasties (TKAs) are performed each year in the United States, with expectations for greater than 4 million/year by the year 2030. Since the onset of TKAs in the 1960's, there have been developments that have improved both functionality and patient satisfaction. In the last decade, a focus has been made on multimodal pain management protocols, more rapid functional recovery, reduced length of hospital stay, and minimizing side effects of treatment while maintaining function and durability. The widespread use of regional anesthesia has led to improvements in pain control, more rapid functional recovery, and reduced length of stay. In recent years many surgeons have transitioned from femoral nerve blocks (proximal femoral nerve) to adductor canal blocks (distal femoral nerve) to maintain a sensory block for pain control, while minimizing any motor blockade that is typically seen in proximal femoral nerve blocks, which would hamper rehabilitation, and increase risk of falls. In addition to regional blocks, which are typically performed in the preoperative setting, some surgeons favor an intraoperative periarticular anesthetic injection (PAI), typically with bupivacaine or the long acting form liposomal bupivacaine, either in conjunction with an adductor canal block, or independently. In theory, PAI has the advantage of a comparable sensory nerve block as an adductor canal block, without the disadvantages and risks, which include prolonged quadriceps weakness, fall risk, and neurologic dysfunction. The purpose of this randomized control trial is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty.

Registry
clinicaltrials.gov
Start Date
July 19, 2016
End Date
November 1, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffrey Geller

Associate Professor of Orthopedic Surgery at the Columbia University Medical Center

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.

Exclusion Criteria

  • Allergy to bupivicaine or liposomal bupivicaine.

Arms & Interventions

Adductor Canal Block

15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. Adductor Canal Block (ACB)

Intervention: Bupivacaine

Periarticular SB

50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.

Intervention: Bupivacaine

ACB + SB

15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery. 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Change in VAS Pain Scores

Time Frame: Day 0 through Day 3

Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain"

Secondary Outcomes

  • Range of Knee Flexion(Postoperative day 21)
  • Length of Hospital Stay(Up to Day 5)
  • Change in Activity Level(Day 0 and Day 1)
  • Opioid Consumption(Day 0 through Day 3)

Study Sites (1)

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