Topical Lidocaine After Major Arthroscopic Knee Surgery

Pain Clinical Trial

Official title:

Topical Lidocaine Patch Does Not Have an Analgesic Effect After Major Arthroscopic Knee Surgery. A Double-blind Place-controlled Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509729
• Other study ID #: N-20110028
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: April 9, 2015
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.

Description:

Lidocaine is well-known as analgesic treatment on skin and hypodermic veins. Since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment.

The aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.

• Patients with synovectomies and menisci resection lasting more than 25 minutes.

• Patients > 18 years

• Acceptance of informed consent

Exclusion Criteria:

• Patients with rheumatoid arthritis

• Patients with a Body Mass index of > 35

• Patients who can not read and understand Danish

• Fertile women who does not use secure contraception

Study Design

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

Related Conditions & MeSH terms

• Fracture of Patella
• Pain

Intervention

Procedure:
• Sham operation
A randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required.
• Knee arthroscopic surgery
A randomized group of patients was given small patches with active 5% lidocaine.

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital	Aalborg

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 analgesic drugs	Time for the first necessary administration of analgesic drugs.	24 hours	Yes
Secondary	Pain management after surgical treatment	The intake of necessary analgesic drugs after 6, 12, 18 and 24 hours after surgical treatment.; Pain score according to the VAS scale when the patients rest and make movements.	24 hours	Yes