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

NCT ID: NCT01068275

Last Updated: 2010-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lumbar plexus catheter

Group Type ACTIVE_COMPARATOR

lumbar plexus catheter

Intervention Type PROCEDURE

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

femoral nerve catheter

Group Type ACTIVE_COMPARATOR

femoral nerve catheter

Intervention Type PROCEDURE

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

single-shot femoral block

Group Type ACTIVE_COMPARATOR

single-shot femoral block

Intervention Type PROCEDURE

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

Interventions

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lumbar plexus catheter

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

Intervention Type PROCEDURE

femoral nerve catheter

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

Intervention Type PROCEDURE

single-shot femoral block

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

Intervention Type PROCEDURE

Other Intervention Names

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psoas compartment catheter

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seattle Children's Hospital

Principal Investigators

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Felicia M Birch, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle Sadler-Greever, RN

Role: CONTACT

206-987-1937

Felicia M. Birch, MD

Role: CONTACT

520-982-0665

Facility Contacts

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Michelle Sadler-Greever, RN

Role: primary

206-987-1937

Felicia M. Birch, MD

Role: backup

206-987-3996

Other Identifiers

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SCHAnes1

Identifier Type: -

Identifier Source: org_study_id

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