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Completed

NCT Number: NCT01509729

Topical Lidocaine After Major Arthroscopic Knee Surgery

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

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Key information

Conditions

Fracture of Patella Fractures, Bone Knee Fractures Neurologic Manifestations Pain Patella Fracture Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham operation

Procedure

A randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required.

Other names: Knee soft-tissue

Knee arthroscopic surgery

Procedure

A randomized group of patients was given small patches with active 5% lidocaine.

Other names: Knee soft-tissue

Primary outcomes

  1. Administration of analgesic drugs

    Time frame: 24 hours

    Time for the first necessary administration of analgesic drugs.

Secondary outcomes

  1. Pain management after surgical treatment

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2012
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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