Clinical trial NCT01106001: Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty
Official title: A Double Blind Randomized Control Trial on the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: total hip arthroplasty
periarticular injection
pain
Lead sponsor: Orthopaedic Research and Innovation Foundation, Ireland
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To determine a significant difference (p>0.05) in morphine consumption between the two treatment groups post-operatively.
timeFrame: 1 year
Secondary outcomes:
measure: To analyse the length of stay for between both treatment groups
timeFrame: Average 6 days (based on precise day of discharge)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Cappagh National Orthopaedic Hospital
state: Finglas
city: Dublin
country: Ireland
facility: Orthopaedic Research and Innovation Foundation
state: Santry
Study officials:
affiliation: Orthopaedic Research and Innovation Foundation, Ireland
name: Kevin J Mulhall
role: PRINCIPAL_INVESTIGATOR
References:
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