Topical Lidocaine After Arthroscopy on Knee

NCT ID: NCT02460627

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Topical Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lidocaine adhesive tape

Group Type EXPERIMENTAL

Lidocaine adhesive tape

Intervention Type DRUG

700 mg for 12 hours

Adhesive tape

Group Type PLACEBO_COMPARATOR

Adhesive tape

Intervention Type OTHER

For 12 hours

Interventions

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Lidocaine adhesive tape

700 mg for 12 hours

Intervention Type DRUG

Adhesive tape

For 12 hours

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aalborg University Hospital

Aalborg, Region of Northern Jutland, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Sten Rasmussen, M.D.

Role: CONTACT

25520462 ext. 45

Sofie S. Lang

Role: CONTACT

Other Identifiers

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N-20150006

Identifier Type: -

Identifier Source: org_study_id

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