Topical Lidocaine After Arthroscopy on Knee

Study Overview
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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.

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

Conditions
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Postoperative Pain, Topical Anaesthesia

Intervention / Treatment
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* Drug: Lidocaine adhesive tape
* Other: Adhesive tape


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine adhesive tape<br> | Drug: Lidocaine adhesive tape<br>* 700 mg for 12 hours<br>|
| Placebo Comparator: Adhesive tape<br> | Other: Adhesive tape<br>* For 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopy, Meniscus, Lidocaine