Analgesic Control Following Knee Arthroscopy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Knee Arthroscopy Analgesia |
Procedure: Intraarticular injection Procedure: Intra-articular injection of 0.5% Bupivacaine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Analgesic Control Following Knee Arthroscopy: Results of a Randomised , Double-blinded Trial Comparing a Hyaluronic Acid Supplement to Bupivacaine |
- Visual Analogue Scale pain score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Visual Analogue Scale pain score [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Visual Analogue Scale pain score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Visual Analogue Scale pain score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 98 |
| Study Start Date: | January 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Durolane |
Procedure: Intraarticular injection
Durolane, one vial
|
| Placebo Comparator: Bupivacaine | 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Ireland | |
| Sports Surgery Clinic | |
| Dublin, Ireland | |
| Principal Investigator: | Kevin J Mulhall, FRCSI | Orthopaedic Research and Innovation Foundation |
More Information
No publications provided
| Responsible Party: | Kevin Mulhall, Orthopaedic Research and Innovation Foundation |
| ClinicalTrials.gov Identifier: | NCT01169389 History of Changes |
| Other Study ID Numbers: | KM/10/2008/18 |
| Study First Received: | July 23, 2010 |
| Last Updated: | July 29, 2010 |
| Health Authority: | Ireland: Research Ethics Committee |
Additional relevant MeSH terms:
|
Analgesics Bupivacaine Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Local Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013