Topical Lidocaine After Major Arthroscopic Knee Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01509729
First received: November 29, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.


Condition Intervention
Fracture of Patella
Pain
Procedure: Sham operation
Procedure: Knee arthroscopic surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Administration of analgesic drugs [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Time for the first necessary administration of analgesic drugs.


Secondary Outcome Measures:
  • Pain management after surgical treatment [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    The intake of necessary analgesic drugs after 6, 12, 18 and 24 hours after surgical treatment.

    Pain score according to the VAS scale when the patients rest and make movements.



Enrollment: 21
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham operation Procedure: Sham operation
A randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required.
Other Name: Knee soft-tissue
Active Comparator: Knee arthroscopic surgery Procedure: Knee arthroscopic surgery
A randomized group of patients was given small patches with active 5% lidocaine.
Other Name: Knee soft-tissue

Detailed Description:

Lidocaine is well-known as analgesic treatment on skin and hypodermic veins. Since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment.

The aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.
  • Patients with synovectomies and menisci resection lasting more than 25 minutes.
  • Patients > 18 years
  • Acceptance of informed consent

Exclusion Criteria:

  • Patients with rheumatoid arthritis
  • Patients with a Body Mass index of > 35
  • Patients who can not read and understand Danish
  • Fertile women who does not use secure contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509729

Locations
Denmark
Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Study Chair: Sten Rasmussen, MD Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Principal Investigator: Marthe Mari O. Bjerke, Stud.med. Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Principal Investigator: Kirstine J. Bennedsgaard, Stud.med. Orthopaedic Research Unit, Aalborg University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01509729     History of Changes
Other Study ID Numbers: N-20110028
Study First Received: November 29, 2011
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Knee
Arthroscopy
Lidocaine patch
Pain management after knee arthroscopy

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014