Comparison of Infiltration Analgesia With Femoral Nerve Block After Hamstrings Anterior Cruciate Ligament Reconstruction
Primary Purpose
Injury of Anterior Cruciate Ligament
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Femoral nerve block
Local infiltration analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Injury of Anterior Cruciate Ligament
Eligibility 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.
Sites / Locations
- Regional Hospital Horsens
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Naropin, Adrenalin, applicationsite
Femoral nerve block
Arm Description
Outcomes
Primary Outcome Measures
Numeric Rang Scale pain
Secondary Outcome Measures
use of analgetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01260363
Brief Title
Comparison of Infiltration Analgesia With Femoral Nerve Block After Hamstrings Anterior Cruciate Ligament Reconstruction
Official Title
Pain Treatment After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Anterior Cruciate Ligament
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naropin, Adrenalin, applicationsite
Arm Type
Active Comparator
Arm Title
Femoral nerve block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block
Other Intervention Name(s)
FNB
Intervention Description
Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml
Intervention Type
Procedure
Intervention Name(s)
Local infiltration analgesia
Other Intervention Name(s)
LIA teknik
Intervention Description
Local infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites.
Primary Outcome Measure Information:
Title
Numeric Rang Scale pain
Time Frame
1 day after operation
Secondary Outcome Measure Information:
Title
use of analgetics
Time Frame
0h, 3h, 24h, 48h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theis Thillemann, MD, Ph.d.
Organizational Affiliation
Regional hospital Horsens, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital Horsens
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23338666
Citation
Kristensen PK, Pfeiffer-Jensen M, Storm JO, Thillemann TM. Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):317-23. doi: 10.1007/s00167-013-2399-x. Epub 2013 Jan 23.
Results Reference
derived
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Comparison of Infiltration Analgesia With Femoral Nerve Block After Hamstrings Anterior Cruciate Ligament Reconstruction
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