Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title: A Double Blind Randomized Control Trial on the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

Status Completed

Clinical Trial Summary

The hypothesis of this study is that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. Patients were randomised in the operating room to receive either a periarticular infiltration, or a placebo consisting of Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.

Clinical Trial Description

The efficacy of periarticular injections during total knee arthroplasty is well established but there is little published data on their effect in primary hip arthroplasty. We hypothesized that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. A double blinded, randomised, placebo-controlled trial on patients undergoing primary hip arthroplasty was performed. Patients were randomised in theatre to receive either a periarticular infiltration of 150mg levobupivicaine in 60mls of 0.9% Saline, or a placebo consisting of 60mls 0.9% Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

• NCT number: NCT01106001
• Study type: Interventional
• Source: Orthopaedic Research and Innovation Foundation
• Status: Completed
• Phase: Phase 4
• Start date: September 2008
• Completion date: September 2009