Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty

NCT02777749 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: AAAQ0850
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in VAS Pain Scores

  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"

  Day 0 through Day 3

Secondary Outcomes (4)

• Change in Activity Level

  Day 0 and Day 1

• Opioid Consumption

  Day 0 through Day 3

• Range of Knee Flexion

  Postoperative day 21

• Length of Hospital Stay

  Up to Day 5

Study Arms (3)

Adductor Canal Block

ACTIVE COMPARATOR

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)

Drug: Bupivacaine

Periarticular SB

ACTIVE COMPARATOR

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

Drug: Bupivacaine

ACB + SB

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection

Also known as: Bupivacaine Hydrochloride, Marcaine

ACB + SB; Adductor Canal Block; Periarticular SB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Allergy to bupivicaine or liposomal bupivicaine.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (7)

• Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012 Sep 26;308(12):1227-36. doi: 10.1001/2012.jama.11153.

  PMID: 23011713 BACKGROUND

• Berend ME, Berend KR, Lombardi AV Jr. Advances in pain management: game changers in knee arthroplasty. Bone Joint J. 2014 Nov;96-B(11 Supple A):7-9. doi: 10.1302/0301-620X.96B11.34514.

  PMID: 25381400 BACKGROUND

• Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.

  PMID: 20966667 BACKGROUND

• Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.

  PMID: 25376972 BACKGROUND

• Wang C, Cai XZ, Yan SG. Comparison of Periarticular Multimodal Drug Injection and Femoral Nerve Block for Postoperative Pain Management in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2015 Jul;30(7):1281-6. doi: 10.1016/j.arth.2015.02.005. Epub 2015 Feb 20.

  PMID: 25735501 BACKGROUND

• Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3.

  PMID: 26117072 BACKGROUND

• Berry J. Audience response-practice norm/trends. 22nd Annual Meeting of the American Association of Hip and Knee Surgeons. American Association of Hip and Knee Surgeons. November 2012.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Matthew Grosso
• Organization: Columbia University Medical Center

mgrosso13@gmail.com

2123058193

Study Officials

• Jeffrey Geller, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopedic Surgery at the Columbia University Medical Center

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 19, 2016
• Study Start: July 19, 2016
• Primary Completion: September 19, 2017
• Study Completion: November 1, 2017
• Last Updated: March 20, 2019
• Results First Posted: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)