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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lumbar plexus catheter
femoral nerve catheter
single-shot femoral block
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring anterior cruciate ligament, pain, postoperative, peripheral nerve catheter, nerve block, Children undergoing anterior cruciate ligament repair

Eligibility Criteria

11 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lumbar plexus catheter

femoral nerve catheter

single-shot femoral block

Arm Description

Outcomes

Primary Outcome Measures

Postoperative pain scores

Secondary Outcome Measures

Quality of recovery
Opioid consumption
Opioid side effects

Full Information

First Posted
February 11, 2010
Last Updated
August 24, 2010
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01068275
Brief Title
Lumbar Plexus Catheter Versus Femoral Nerve Catheter for Postoperative Pain After Anterior Cruciate Ligament (ACL) Repair
Official Title
Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
anterior cruciate ligament, pain, postoperative, peripheral nerve catheter, nerve block, Children undergoing anterior cruciate ligament repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumbar plexus catheter
Arm Type
Active Comparator
Arm Title
femoral nerve catheter
Arm Type
Active Comparator
Arm Title
single-shot femoral block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
lumbar plexus catheter
Other Intervention Name(s)
psoas compartment catheter
Intervention Description
lumbar plexus catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
Intervention Type
Procedure
Intervention Name(s)
femoral nerve catheter
Intervention Description
femoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
Intervention Type
Procedure
Intervention Name(s)
single-shot femoral block
Intervention Description
single-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml)
Primary Outcome Measure Information:
Title
Postoperative pain scores
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Quality of recovery
Time Frame
72 hours
Title
Opioid consumption
Time Frame
72 hours
Title
Opioid side effects
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Sadler-Greever, RN
Phone
206-987-1937
Email
michelle.sadler-greever@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia M. Birch, MD
Phone
520-982-0665
Email
felicia.birch@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicia M Birch, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Sadler-Greever, RN
Phone
206-987-1937
First Name & Middle Initial & Last Name & Degree
Felicia M. Birch, MD
Phone
206-987-3996
First Name & Middle Initial & Last Name & Degree
Benjamin Walker, MD
First Name & Middle Initial & Last Name & Degree
Sean Flack, MBChB
First Name & Middle Initial & Last Name & Degree
Adrian Bosenberg, MBChB
First Name & Middle Initial & Last Name & Degree
Gregory Schmale, MD
First Name & Middle Initial & Last Name & Degree
Martha Pankovich, MD
First Name & Middle Initial & Last Name & Degree
Carmen Bernardo-Ocampo, MD
First Name & Middle Initial & Last Name & Degree
Michelle Sadler-Greever, RN
First Name & Middle Initial & Last Name & Degree
Felicia Birch, MD

12. IPD Sharing Statement

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

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