Topical Lidocaine After Arthroscopy on Knee

June 1, 2015 updated by: Northern Orthopaedic Division, Denmark

Postoperative Pain Management With Topical Lidocaine After Arthroscopy on Knee. A Randomized Double-blind Study

More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.

The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.

It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.

The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.

This study is planned to be a pilot study in order to complete a future large medical science study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Denmark
    • Region of Northern Jutland
      • Aalborg, Region of Northern Jutland, Denmark, 9000
        • Aalborg University 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 to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned resection of meniscus (DS832, DM232)
  • Planned meniscus suture (DS832)
  • Planned plica resection (DM659)
  • Patients >=18 years and <50 years
  • Statement of consent
  • Tolerance to Lidocaine (analgesics)

Exclusion Criteria:

  • Type 1 diabetes or type 2 diabetes
  • Allergic to Lidocaine (analgesics)
  • Heart disease, liver disease, kidney disease
  • BMI >=35
  • Unability to read or speak Danish
  • Rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage
  • Insufficient coagulation
  • Medication of morphine pre-operatively
  • Pregnant and nursing women

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine adhesive tape
Drug: Lidocaine adhesive tape
700 mg for 12 hours
Placebo Comparator: Adhesive tape
Other: Adhesive tape
For 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of analgesics or morphine in time
Time Frame: 1 day
First time administration of analgesics or morphine in time on demand
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharges of patients in time
Time Frame: 1 day
1 day
Value Added Score (VAS) estimation of pain
Time Frame: 1 day
Estimate pain at each administration of analgesics on demand before discharge of patients.
1 day

Collaborators and Investigators

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

Sponsor

Northern Orthopaedic Division, 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

May 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20150006

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.

Clinical Trials on Postoperative Pain

Clinical Trials on Lidocaine adhesive tape

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe