Analgesic Control Following Knee Arthroscopy

This study has been completed.
Sponsor:
Information provided by:
Orthopaedic Research and Innovation Foundation
ClinicalTrials.gov Identifier:
NCT01169389
First received: July 23, 2010
Last updated: July 29, 2010
Last verified: December 2008
  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

Resource links provided by NLM:


Further study details as provided by Orthopaedic Research and Innovation Foundation:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169389

Locations
Ireland
Sports Surgery Clinic
Dublin, Ireland
Sponsors and Collaborators
Orthopaedic Research and Innovation Foundation
Investigators
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 July 24, 2014