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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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury of Anterior Cruciate Ligament

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 6, 2010
Last Updated
May 1, 2012
Sponsor
University of Aarhus
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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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