Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777749
• Other study ID #: AAAQ0850
• Status: Completed
• Phase: Phase 4
• Start date: July 19, 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: March 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: November 1, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Activity Level	Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited.	Day 0 and Day 1
Secondary	Opioid Consumption	Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited.	Day 0 through Day 3
Secondary	Range of Knee Flexion	Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion.	Postoperative day 21
Secondary	Length of Hospital Stay	Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days.	Up to Day 5