Topical Lidocaine After Arthroscopy on Knee

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02460627
• Other study ID #: N-20150006
• Status: Not yet recruiting
• Phase: Phase 1
• First received: May 29, 2015
• Last updated: June 1, 2015
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: May 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: Sten Rasmussen, M.D.
• Phone: 25520462
• Email: sten.rasmussen[@]rn.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Topical Anaesthesia

Intervention

Drug:
• Lidocaine adhesive tape
700 mg for 12 hours

Other:
• Adhesive tape
For 12 hours

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region of Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Administration of analgesics or morphine in time	First time administration of analgesics or morphine in time on demand	1 day	Yes
Secondary	Discharges of patients in time		1 day	No
Secondary	Value Added Score (VAS) estimation of pain	Estimate pain at each administration of analgesics on demand before discharge of patients.	1 day	No