Recruiting

Lumbar Plexus vs. Femoral Nerve

Sponsor:

Seattle Children's Hospital

Code:

NCT01068275

Conditions

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Not accepted

Interventions

lumbar plexus catheter

femoral nerve catheter

single-shot femoral block

Study Details

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.

Conditions

Postoperative Pain

Study ID

NCT01068275

Start date

Apr, 2010

Status verified date

Aug, 2010

Completion date

Sep, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lumbar plexus catheter

active comparator: femoral nerve catheter

active comparator: single-shot femoral block

Interventions

lumbar plexus catheter

lumbar plexus catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)

femoral nerve catheter

femoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)

single-shot femoral block

single-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml)

Primary outcome measure

  • Postoperative pain scores [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

Michelle Sadler-Greever, RN

206-987-1937michelle.sadler-greever@seattlechildrens.org

Felicia M. Birch, MD

520-982-0665felicia.birch@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Michelle Sadler-Greever, RN

206-987-1937

Felicia M. Birch, MD

206-987-3996

Principal Investigator:

Felicia Birch, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Aug 26, 2010

Last verified

Aug, 2010

Keywords

  • anterior cruciate ligament
  • pain, postoperative
  • peripheral nerve catheter
  • nerve block
  • Children undergoing anterior cruciate ligament repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2010-08-26.