MedTrace Logo

Trial of Liposomal Bupivacaine for TKA

NCT05635916 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-07-07

No results posted yet for this study

Summary

Total knee arthroplasty (TKA), also known as a knee replacement, is a procedure performed to reduce severe pain and improve function of the joint. Managing postoperative pain can be challenging following TKA, and inadequate relief can lead to impaired mobility and persistent opioid use. Adductor canal nerve blocks (ACB), have shown significant benefit in improving postoperative analgesia and patient satisfaction. However, the local anesthetic used currently for these blocks only provides temporary relief that wears off within 24 hours. Liposomal bupivacaine is an extended-release local anesthetic agent that can provide up to 72 hours of pain relief, however it is unclear if its use is also effective in ACBs for knee surgery. The purpose of this study is to determine if liposomal bupivacaine is better than conventional bupivacaine in improving pain control, opioid consumption, and length of stay in patients scheduled for TKA.

Conditions

  • Knee Replacement
  • Total Knee Arthroplasty
  • Post-Operative Pain

Interventions

DRUG

Liposomal bupivacaine

Adductor canal block with injection of 10cc 13.3% liposomal bupivacaine combined with 10cc 0.50% bupivacaine within one hour following surgery

DRUG

Bupivacaine

Adductor canal block with injection of 20cc 0.5% bupivacaine within one hour following surgery

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER

  • Northern Light Mercy Hospital

    lead OTHER

Principal Investigators

  • Brian McAllister, MD · Medical Staff & Chief of Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2023-04-11
Completion
2023-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635916 on ClinicalTrials.gov