Topical Lidocaine After Arthroscopy on Knee

Phase 1

• Conditions: Postoperative Pain; Topical Anaesthesia
• Interventions: Drug: Lidocaine adhesive tape; Other: Adhesive tape

• Registration Number: NCT02460627
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-01
• Last Update Submitted: 2015-06-01
• Study First Posted: 2015-06-02
• Last Update Posted: 2015-06-02
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine adhesive tape	Lidocaine adhesive tape	-
Adhesive tape	Adhesive tape	-

Primary Outcome Measures

Name	Time	Method
Administration of analgesics or morphine in time	1 day	First time administration of analgesics or morphine in time on demand

Secondary Outcome Measures

Name	Time	Method
Discharges of patients in time	1 day
Value Added Score (VAS) estimation of pain	1 day	Estimate pain at each administration of analgesics on demand before discharge of patients.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Region of Northern Jutland, Denmark