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

Injury of Anterior Cruciate Ligament Clinical Trial

Official title:

Pain Treatment After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260363
• Other study ID #: 2010-022500-50
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2010
• Last updated: May 1, 2012
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Injury of Anterior Cruciate Ligament

Intervention

Procedure:
• Femoral nerve block
Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml
• Local infiltration analgesia
Local infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites.

Locations

Country	Name	City	State
Denmark	Regional Hospital Horsens	Horsens

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rang Scale pain		1 day after operation	No
Secondary	use of analgetics		0h, 3h, 24h, 48h	No