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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Aarhus

Additional 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
Study First Received: December 6, 2010
Last Updated: May 1, 2012
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on November 27, 2014