Topical Lidocaine After Major Arthroscopic Knee Surgery

NCT ID: NCT01509729

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Fracture of Patella Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sham operation

Group Type PLACEBO_COMPARATOR

Sham operation

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Knee arthroscopic surgery

Intervention Type PROCEDURE

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

Interventions

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Sham operation

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

Intervention Type PROCEDURE

Knee arthroscopic surgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Knee soft-tissue Knee soft-tissue

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sten Rasmussen, MD

Role: STUDY_CHAIR

Orthopaedic Research Unit, Aalborg University Hospital, Denmark

Marthe Mari O. Bjerke, Stud.med.

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Research Unit, Aalborg University Hospital, Denmark

Kirstine J. Bennedsgaard, Stud.med.

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Research Unit, Aalborg University Hospital, Denmark

Locations

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Orthopaedic Surgery Research Unit, Aarhus University, Aalborg Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20110028

Identifier Type: -

Identifier Source: org_study_id

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