Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

Opioid Use Clinical Trial

Official title:

Does the Addition of Liposomal Bupivacaine to the Adductor Canal Block Impact Narcotic Use After Primary Total Knee Arthroplasty: a Prospective, Blind Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04539730
• Other study ID #: 20200003
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject is scheduled for elective unilateral primary TKA

2. The subject is = 18 years

3. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)

4. The patient consents for an adductor canal block

5. Willing and able to sign an informed consent.

Exclusion Criteria:

1. Patients unwilling or unable to consent to participate in the study.

2. Prisoners.

3. Pregnancy.

4. Reported to have mental illness or belonging to a vulnerable population.

5. Subject is < 18 years of age.

6. Patients receiving general anesthesia for the total knee arthroplasty.

7. Subject has impaired decision-making capacity per discretion of the Investigator.

8. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.

9. Significant pre-existing neuropathy on the operative limb.

10. Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I & II, among others).

11. Subject has sustained a significant trauma to the operative knee.

12. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).

13. Known hypersensitivity and/or allergies to local anesthetics.

14. Previous surgery on the affected knee excluding arthroscopic or open meniscectomy.

15. Patients with impaired renal function such that they cannot receive IV Toradol.

Related Conditions & MeSH terms

• Adductor Canal Block
• Arthroplasty Complications
• Opioid Use
• Peripheral Nerve Block

Intervention

Drug:
• Liposomal bupivacaine
266 mg or 20 ml Liposomal Bupivacaine injectable solution

Procedure:
• Drug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

References & Publications (9)

Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4. — 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

Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. — View Citation

Jain RK, Porat MD, Klingenstein GG, Reid JJ, Post RE, Schoifet SD. The AAHKS Clinical Research Award: Liposomal Bupivacaine and Periarticular Injection Are Not Superior to Single-Shot Intra-articular Injection for Pain Control in Total Knee Arthroplasty. J Arthroplasty. 2016 Sep;31(9 Suppl):22-5. doi: 10.1016/j.arth.2016.03.036. Epub 2016 Mar 26. — 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

Singh PM, Borle A, Trikha A, Michos L, Sinha A, Goudra B. Role of Periarticular Liposomal Bupivacaine Infiltration in Patients Undergoing Total Knee Arthroplasty-A Meta-analysis of Comparative Trials. J Arthroplasty. 2017 Feb;32(2):675-688.e1. doi: 10.1016/j.arth.2016.09.042. Epub 2016 Oct 8. Review. — View Citation

Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16. — View Citation

Thacher RR, Hickernell TR, Grosso MJ, Shah R, Cooper HJ, Maniker R, Brown AR, Geller J. Decreased risk of knee buckling with adductor canal block versus femoral nerve block in total knee arthroplasty: a retrospective cohort study. Arthroplast Today. 2017 Apr 15;3(4):281-285. doi: 10.1016/j.artd.2017.02.008. eCollection 2017 Dec. — View Citation

Zhao B, Ma X, Zhang J, Ma J, Cao Q. The efficacy of local liposomal bupivacaine infiltration on pain and recovery after Total Joint Arthroplasty: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Jan;98(3):e14092. doi: 10.1097/MD.0000000000014092. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents	Up to 2 weeks
Secondary	Distance Ambulated with physical therapist	Average daily distance ambulated using the 6 minute walk test	Up to 5 days
Secondary	Length of hospitalization	Number of days of hospitalization after elective admission for TKA surgery	Up to 5 days
Secondary	Incidence of events of PONV	Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization	Up to 5 days
Secondary	Number of participants requiring narcotic prescriptions	The number of participants that require further narcotic prescriptions will be reported	2 weeks
Secondary	Incidence of urinary retention from narcotic use	Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization.	2 Weeks
Secondary	Post-Operative Pain Score	Post-Operative Pain will be measured via a self-reported Visual Analog Scale (VAS) score. The VAS Pain score ranges from 1-10 with 1 being free of pain and 10 being the most pain.	Up to 5 days
Secondary	Patient Satisfaction as per the Knee Society Score	The Knee society score has a total score ranging from 100-0. Scores between 100 and 85 points are considered excellent results, scores between 84 and 70 points are considered good results. Scores between 69 and 60 points are considered fair, and scores less than 60 are considered poor results	Up to Week 6

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