Analgesic Control Following Knee Arthroscopy

Study Overview
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Brief Summary
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This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.

Detailed Description
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There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.

Official Title
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Analgesic Control Following Knee Arthroscopy: Results of a Randomised , Double-blinded Trial Comparing a Hyaluronic Acid Supplement to Bupivacaine

Conditions
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Knee, Arthroscopy, Analgesia

Intervention / Treatment
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* Procedure: Intraarticular injection
* Procedure: Intra-articular injection of 0.5% Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy age over 18 years Exclusion Criteria: American Society of Anaesthesiologists (ASA) grade ≥3; arthroscopic assisted osteotomies; a history of two or more prior procedures on the ipsilateral knee; post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE); systemic steroid requirements; previous intra-articular anaesthetic or steroid injection within the last three months; intra-articular HA injection within the last nine months; intra-articular sepsis within the previous three months; prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Durolane<br> | Procedure: Intraarticular injection<br>* Durolane, one vial<br>|
| Placebo Comparator: Bupivacaine<br> | Procedure: Intra-articular injection of 0.5% Bupivacaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale pain score |  | 1 day | 
| Visual Analogue Scale pain score |  | 1 week | 
| Visual Analogue Scale pain score |  | 2 weeks | 
| Visual Analogue Scale pain score |  | 6 weeks |