CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
Levobupivacaine +1 moredrug
Likely dose
Levobupivacaine 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01106001
NCT01106001Phase 4Completed

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

Orthopaedic Research and Innovation Foundation, Ireland·interventional·Posted Apr 19, 2010·Updated Apr 19, 2010

In Brief

A Phase 4 clinical trial evaluating Levobupivacaine and Saline for Osteoarthritis. Completed, enrolled 91 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesIreland
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2010
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.2 years ago

Interventions

Levobupivacainedrug

The treatment group received 150mg of levobupivicaine in 60mls of 0.9% saline. This was injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.

Salinedrug

The placebo group received 60mls of 0.9% saline injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.