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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01260363
First Posted: December 15, 2010
Last Update Posted: May 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  Purpose
Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.

Condition Intervention Phase
Injury of Anterior Cruciate Ligament Procedure: Femoral nerve block Procedure: Local infiltration analgesia Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pain Treatment After Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Numeric Rang Scale pain [ Time Frame: 1 day after operation ]

Secondary Outcome Measures:
  • use of analgetics [ Time Frame: 0h, 3h, 24h, 48h ]

Enrollment: 60
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: LIA teknik
Active Comparator: Femoral nerve block Procedure: Femoral nerve block
Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml
Other Name: FNB

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260363


Locations
Denmark
Regional Hospital Horsens
Horsens, Denmark, 8700
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Theis Thillemann, MD, Ph.d. Regional hospital Horsens, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01260363     History of Changes
Other Study ID Numbers: 2010-022500-50
First Submitted: December 6, 2010
First Posted: December 15, 2010
Last Update Posted: May 2, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries