Topical Lidocaine After Major Arthroscopic Knee Surgery

April 9, 2015 updated by: Northern Orthopaedic Division, Denmark

Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Knee soft-tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of analgesic drugs
Time Frame: 24 hours
Time for the first necessary administration of analgesic drugs.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

January 12, 2012

First Posted (ESTIMATE)

January 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N-20110028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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