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

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ClinicalTrials.gov Identifier: NCT01068275
Recruitment Status : Unknown
Verified August 2010 by Seattle Children's Hospital.
Recruitment status was:  Recruiting
First Posted : February 12, 2010
Last Update Posted : August 26, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Postoperative Pain Procedure: lumbar plexus catheter Procedure: femoral nerve catheter Procedure: single-shot femoral block

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Quality of recovery [ Time Frame: 72 hours ]
  2. Opioid consumption [ Time Frame: 72 hours ]
  3. Opioid side effects [ Time Frame: 72 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068275

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, 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
Principal Investigator: Felicia M Birch, MD Seattle Children's Hospital
More Information

Responsible Party: Felicia Birch, M.D., Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01068275     History of Changes
Other Study ID Numbers: SCHAnes1
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: August 26, 2010
Last Verified: August 2010

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
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms