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Topical Lidocaine After Major Arthroscopic Knee Surgery

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. Identifier: NCT01509729
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

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

Condition or disease Intervention/treatment Phase
Fracture of Patella Pain Procedure: Sham operation Procedure: Knee arthroscopic surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Administration of analgesic drugs [ Time Frame: 24 hours ]
    Time for the first necessary administration of analgesic drugs.

Secondary Outcome Measures :
  1. Pain management after surgical treatment [ Time Frame: 24 hours ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01509729

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

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Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT01509729     History of Changes
Other Study ID Numbers: N-20110028
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Northern Orthopaedic Division, Denmark:
Lidocaine patch
Pain management after knee arthroscopy
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action