Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01260363
First received: December 6, 2010
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pain Treatment After Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Numeric Rang Scale pain [ Time Frame: 1 day after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • use of analgetics [ Time Frame: 0h, 3h, 24h, 48h ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01260363     History of Changes
Other Study ID Numbers: 2010-022500-50
Study First Received: December 6, 2010
Last Updated: May 1, 2012
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on May 19, 2013