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NCT Number: NCT01106001

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cappagh National Orthopaedic Hospital, Dublin, Finglas, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

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.

Saline

Drug

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.

Primary outcomes

  1. To determine a significant difference (p>0.05) in morphine consumption between the two treatment groups post-operatively.

    Time frame: 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 outcomes

  1. To analyse the length of stay for between both treatment groups

    Time frame: Average 6 days (based on precise day of discharge)

Sponsors and collaborators

Lead sponsor

Orthopaedic Research and Innovation Foundation, Ireland

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 19, 2010
Registry last updated
Apr 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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