NCT03326180

Study of Peri-Articular Anaesthetic for Replacement of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 533 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical and cost effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial.

Detailed description

The trial design is a patient-blinded multi-centre, active comparator, randomised controlled two-arm parallel group superiority trial of liposomal bupivacaine plus bupivacaine hydrochloride versus bupivacaine alone for post-operative pain in patients undergoing knee replacement surgery. Patients will be randomised in a 1:1 ratio. The randomised controlled trial (RCT) design is robust and reduces any potential bias. Patients will be blinded as to which treatment they receive. Blinding of patients is possible as they will be under general anaesthetic for their knee replacement surgery at the time of the drug administration. Blinding of surgeons, who administer the medication and outcome assessors was not necessary as the primary outcome is a patient reported outcome measure.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	266mg/20ml vial of EXPAREL
DRUG	Bupivacaine hydrochloride	100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)

Timeline

• Start date: 2018-03-29
• Primary completion: 2021-02-28
• Completion: 2021-04-21
• First posted: 2017-10-31
• Last updated: 2022-11-04

Locations

11 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study