Clonidine in Femoral Nerve Block Surgery in Children

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-03-31

Brief Summary

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Knee arthroscopy is a common surgical procedure in pediatrics in which the knee joint is visualized through a small camera to help diagnose and treat knee problems. This procedure is commonly accomplished with the use of general anesthesia. Regional anesthesia is commonly completed with a single injection of local anesthetic around the femoral nerve to provide pain relief for several hours following knee arthroscopy. The intent of this study is to examine the effects of clonidine in addition to local anesthetics for femoral nerve blockade in providing children and adolescents post-operative analgesia. The investigators hypothesize the addition of low dose clonidine (1 mcg/kg) provides an additional 4 hours of post operative analgesia following arthroscopic knee surgery and reduces post-operative opiate requirement.

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Detailed Description

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Conditions

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Other Reconstructive Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine plus clonidine

Ropivacaine plus clonidine for femoral block

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Ropivacaine

Ropivacaine alone for femoral block

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Interventions

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Ropivacaine

ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Intervention Type DRUG

Clonidine

clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologist (ASA) functional status I or II
* Patients scheduled for arthroscopic knee surgery only

Exclusion Criteria

* Patients with history of chronic opioid therapy, central or peripheral neuropathy, contraindications to regional anesthesia, history of allergy to clonidine or ropivicaine, or anterior cruciate ligament reconstructive surgery in addition to knee arthroscopy

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No