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Lumbar Plexus Catheter Versus Femoral Nerve Catheter for Postoperative Pain After Anterior Cruciate Ligament (ACL) Repair

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Seattle Children's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068275
First Posted: February 12, 2010
Last Update Posted: August 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seattle Children's Hospital
February 11, 2010
February 12, 2010
August 26, 2010
April 2010
September 2012   (Final data collection date for primary outcome measure)
Postoperative pain scores [ Time Frame: 72 hours ]
Same as current
Complete list of historical versions of study NCT01068275 on ClinicalTrials.gov Archive Site
  • Quality of recovery [ Time Frame: 72 hours ]
  • Opioid consumption [ Time Frame: 72 hours ]
  • Opioid side effects [ Time Frame: 72 hours ]
Same as current
Not Provided
Not Provided
 
Lumbar Plexus Catheter Versus Femoral Nerve Catheter for Postoperative Pain After Anterior Cruciate Ligament (ACL) Repair
Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction
Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72 hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus catheter will provide superior pain control and overall quality of recovery compared to femoral nerve catheters.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Procedure: lumbar plexus catheter
    lumbar plexus catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
    Other Name: psoas compartment catheter
  • Procedure: femoral nerve catheter
    femoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
  • Procedure: single-shot femoral block
    single-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml)
  • Active Comparator: Lumbar plexus catheter
    Intervention: Procedure: lumbar plexus catheter
  • Active Comparator: femoral nerve catheter
    Intervention: Procedure: femoral nerve catheter
  • Active Comparator: single-shot femoral block
    Intervention: Procedure: single-shot femoral block
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
114
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA physical status 1-2
  • Age 11-21
  • Undergoing anterior cruciate ligament repair

Exclusion Criteria:

  • Patient refusal
  • Coagulopathy
  • Systemic infection or infection at needle insertion site
  • Allergy to ropivacaine or opioids
  • Taking chronic opioids
  • Unavailable by phone
Sexes Eligible for Study: All
11 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01068275
SCHAnes1
No
Not Provided
Not Provided
Felicia Birch, M.D., Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
Principal Investigator: Felicia M Birch, MD Seattle Children's Hospital
Seattle Children's Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP