Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty
- Registration Number
- NCT01106001
- Lead Sponsor
- Orthopaedic Research and Innovation Foundation, Ireland
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- Consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent.
- Patients with cognitive impairment, neurological disorders, advanced liver or renal impairment, known ischemic heart disease, a previous diagnosis of a pain syndrome or any post-operative surgical or medical complications were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Saline Saline (also saline solution) is a general term referring to a sterile solution of sodium chloride (NaCl, more commonly known as salt) in water but is only sterile when it is placed intravenously, otherwise, a saline solution is a salt water solution. Levobupivacaine Levobupivacaine Levobupivacaine is indicated for local anaesthesia including infiltration, nerve block, ophthalmic, epidural and intrathecal anaesthesia in adults; and infiltration analgesia in children
- Primary Outcome Measures
Name Time Method To determine a significant difference (p>0.05) in morphine consumption between the two treatment groups post-operatively. 1 year The modified McGill pain scale was administered to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. In addition, morphine and analgesic consumption was recorded for each patient. The results were assessed after one year, once all the information from both treatment groups was collected.
- Secondary Outcome Measures
Name Time Method To analyse the length of stay for between both treatment groups Average 6 days (based on precise day of discharge)
Trial Locations
- Locations (2)
Orthopaedic Research and Innovation Foundation
🇮🇪Dublin, Santry, Ireland
Cappagh National Orthopaedic Hospital
🇮🇪Dublin, Finglas, Ireland