Analgesic Control Following Knee Arthroscopy

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169389
• Other study ID #: KM/10/2008/18
• Status: Completed
• Phase: N/A
• First received: July 23, 2010
• Last updated: July 29, 2010
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: December 2008
• Source: Orthopaedic Research and Innovation Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Analgesia
• Arthroscopy
• Knee

Intervention

Procedure:
• Intraarticular injection
Durolane, one vial
• Intra-articular injection of 0.5% Bupivacaine

Locations

Country	Name	City	State
Ireland	Sports Surgery Clinic	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Research and Innovation Foundation

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale pain score		1 day	No
Primary	Visual Analogue Scale pain score		1 week	No
Primary	Visual Analogue Scale pain score		2 weeks	No
Primary	Visual Analogue Scale pain score		6 weeks	No