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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 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
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Procedure: lumbar plexus catheter
Procedure: femoral nerve catheter
Procedure: single-shot femoral block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Postoperative pain scores [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 114
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lumbar plexus catheter 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
Active Comparator: femoral nerve catheter Procedure: femoral nerve catheter
femoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
Active Comparator: single-shot femoral block Procedure: single-shot femoral block
single-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml)

  Eligibility

Ages Eligible for Study:   11 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068275

Contacts
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

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Michelle Sadler-Greever, RN     206-987-1937        
Contact: Felicia M. Birch, MD     206-987-3996        
Sub-Investigator: Benjamin Walker, MD            
Sub-Investigator: Sean Flack, MBChB            
Sub-Investigator: Adrian Bosenberg, MBChB            
Sub-Investigator: Gregory Schmale, MD            
Sub-Investigator: Martha Pankovich, MD            
Sub-Investigator: Carmen Bernardo-Ocampo, MD            
Sub-Investigator: Michelle Sadler-Greever, RN            
Principal Investigator: Felicia Birch, MD            
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Felicia M Birch, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Felicia Birch, M.D., Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01068275     History of Changes
Other Study ID Numbers: SCHAnes1
Study First Received: February 11, 2010
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
anterior cruciate ligament
pain, postoperative
peripheral nerve catheter
nerve block
Children undergoing anterior cruciate ligament repair

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013