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Study of Peri-Articular Anaesthetic for Replacement of the Knee — SPAARK  

Knee Osteoarthritis Clinical Trial

Official title:
Study of Peri-Articular Anaesthetic for Replacement of the Knee

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03326180
Study type Interventional
Source University of Leeds
Contact
Status Completed
Phase Phase 3
Start date March 29, 2018
Completion date April 21, 2021
View Details
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