Analgesic Control Following Knee Arthroscopy

Not Applicable

Completed

• Conditions: Knee; Arthroscopy; Analgesia
• Interventions: Procedure: Intraarticular injection; Procedure: Intra-articular injection of 0.5% Bupivacaine

• Registration Number: NCT01169389
• Lead Sponsor: Orthopaedic Research and Innovation Foundation, Ireland

Brief Summary

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

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.

Study Timeline

• Status Verified: 2008-12
• Study Start: 2009-01
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durolane	Intraarticular injection	-
Bupivacaine	Intra-articular injection of 0.5% Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale pain score	6 weeks

Trial Locations

Locations (1)

Sports Surgery Clinic; 🇮🇪 Dublin, Ireland