Comparison of Infiltration Analgesia With Femoral Nerve Block After Hamstrings Anterior Cruciate Ligament Reconstruction

May 1, 2012 updated by: University of Aarhus

Pain Treatment After Anterior Cruciate Ligament Reconstruction

Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

  • Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
  • Age > 18 year

Exclusion Criteria:

  • Revision ACL reconstruction
  • Patients with cartilige lision
  • Patients with arthritis
  • Pregnant women.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Horsens, Denmark, 8700
        • Regional Hospital Horsens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
  • Age > 18 year

Exclusion Criteria:

  • Revision ACL reconstruction
  • Patients with cartilige lision
  • Patients with arthritis
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Naropin, Adrenalin, applicationsite
Procedure: Local infiltration analgesia
Local infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites.
Other Names:
  • LIA teknik
Active Comparator: Femoral nerve block
Procedure: Femoral nerve block
Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml
Other Names:
  • FNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric Rang Scale pain
Time Frame: 1 day after operation
1 day after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
use of analgetics
Time Frame: 0h, 3h, 24h, 48h
0h, 3h, 24h, 48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Theis Thillemann, MD, Ph.d., Regional hospital Horsens, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-022500-50

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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