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

Postoperative Pain Clinical Trial

Official title:

Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01068275
• Other study ID #: SCHAnes1
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2010
• Last updated: August 24, 2010
• Start date: April 2010
• Est. completion date: September 2012

Study information

• Verified date: August 2010
• Source: Seattle Children's Hospital
• Contact: Michelle Sadler-Greever, RN
• Phone: 206-987-1937
• Email: michelle.sadler-greever[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores		72 hours	No
Secondary	Quality of recovery		72 hours	No
Secondary	Opioid consumption		72 hours	No
Secondary	Opioid side effects		72 hours	No