NCT01068275

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 26, 2010

Status Verified

August 1, 2010

Enrollment Period

2.4 years

First QC Date

February 11, 2010

Last Update Submit

August 24, 2010

Conditions

Postoperative Pain

Keywords

anterior cruciate ligamentpain, postoperativeperipheral nerve catheternerve blockChildren undergoing anterior cruciate ligament repair

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores

    72 hours

Secondary Outcomes (3)

  • Quality of recovery

    72 hours

  • Opioid consumption

    72 hours

  • Opioid side effects

    72 hours

Study Arms (3)

Lumbar plexus catheter

ACTIVE COMPARATOR
Procedure: lumbar plexus catheter

femoral nerve catheter

ACTIVE COMPARATOR
Procedure: femoral nerve catheter

single-shot femoral block

ACTIVE COMPARATOR
Procedure: single-shot femoral block

Interventions

lumbar plexus catheterPROCEDURE

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

Also known as: psoas compartment catheter
Lumbar plexus catheter
femoral nerve catheterPROCEDURE

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

femoral nerve catheter
single-shot femoral blockPROCEDURE

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

single-shot femoral block

Eligibility Criteria

Age11 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA physical status 1-2
  • Age 11-21
  • Undergoing anterior cruciate ligament repair

You may not qualify if:

  • Patient refusal
  • Coagulopathy
  • Systemic infection or infection at needle insertion site
  • Allergy to ropivacaine or opioids
  • Taking chronic opioids
  • Unavailable by phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Felicia M Birch, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Sadler-Greever, RN

CONTACT

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

Felicia M. Birch, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 26, 2010

Record last verified: 2010-08

Locations

US(1)