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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Seattle Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01068275
First received: February 11, 2010
Last updated: August 24, 2010
Last verified: August 2010

February 11, 2010
August 24, 2010
April 2010
September 2012   (final data collection date for primary outcome measure)
Postoperative pain scores [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01068275 on ClinicalTrials.gov Archive Site
  • Quality of recovery [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Opioid consumption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Opioid side effects [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Recruiting
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
Both
11 Years to 21 Years
No
Contact: Michelle Sadler-Greever, RN 206-987-1937 michelle.sadler-greever@seattlechildrens.org
Contact: Felicia M. Birch, MD 520-982-0665 felicia.birch@seattlechildrens.org
United States
 
NCT01068275
SCHAnes1
No
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