NCT06740214

Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty

Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Poor acute postoperative pain control impacts rehabilitation, prolongs recovery and increases opioid consumption and chronic post-surgical pain. Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals Inc, Parsippany, New Jersey, USA) is a multivesicular formulation of bupivacaine that prolongs drug release and can extend the duration of analgesia. The adductor canal block (ACB) has been shown to reduce pain intensity and opioid consumption after total knee arthroplasty. The use of liposomal bupivacaine in the adductor canal block has recently been FDA-approved. However, the results of its efficacy from existing clinical trials have been mixed. In addition, the doses in the clinical trials have been different, and the optimal dose for perineural application of liposomal bupivacaine is unclear, including for the adductor canal block. In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of different doses of liposomal bupivacaine in the adductor canal block on acute postoperative pain intensity and opioid consumption after robotic assisted total knee arthroplasty. The investigators will also assess secondary outcomes including knee functional scores, chronic pain and quality of recovery.

Conditions

• Pain, Postoperative
• Analgesic Effect
• Total Knee Arthroplasty
• Liposomal Bupivacaine
• Dose Response Relationship, Drug

Interventions

Type	Name	Description
DRUG	0.5% standard bupivacaine only	20ml 0.5% standard bupivacaine only
DRUG	1.33% liposomal bupivacaine with 0.5% standard bupivacaine	10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
DRUG	1.33% liposomal bupivacaine only	20ml 1.33% liposomal bupivacaine (266mg)

Timeline

• Start date: 2025-09-04
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2024-12-18
• Last updated: 2025-11-24

Locations

1 site across 1 country: Hong Kong