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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01169389
Other study ID # KM/10/2008/18
Secondary ID
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


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
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