Analgesic Control Following Knee Arthroscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Knee; Arthroscopy
• Intervention / Treatment: Procedure: Intraarticular injection; Procedure: Intra-articular injection of 0.5% Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Sports Surgery Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Durolane	Procedure: Intraarticular injection; Durolane, one vial
PLACEBO_COMPARATOR: Bupivacaine	Procedure: Intra-articular injection of 0.5% Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Orthopaedic Research and Innovation Foundation, Ireland
• Investigators: Principal Investigator: Kevin J Mulhall, FRCSI, Orthopaedic Research and Innovation Foundation, Ireland

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: July 23, 2010
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (ESTIMATE): July 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2010
• Last Update Submitted That Met QC Criteria: July 29, 2010
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: KM/10/2008/18