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Analgesic Control Following Knee Arthroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169389
First Posted: July 26, 2010
Last Update Posted: July 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orthopaedic Research and Innovation Foundation
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
  • Visual Analogue Scale pain score [ Time Frame: 1 week ]
  • Visual Analogue Scale pain score [ Time Frame: 2 weeks ]
  • Visual Analogue Scale pain score [ Time Frame: 6 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kevin Mulhall, Orthopaedic Research and Innovation Foundation
ClinicalTrials.gov Identifier: NCT01169389     History of Changes
Other Study ID Numbers: KM/10/2008/18
First Submitted: July 23, 2010
First Posted: July 26, 2010
Last Update Posted: July 30, 2010
Last Verified: December 2008

Additional relevant MeSH terms:
Bupivacaine
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents