Clonidine in Femoral Nerve Block Surgery in Children

Phase 2

Withdrawn

• Conditions: Other Reconstructive Surgery
• Interventions: Drug: Clonidine; Drug: Ropivacaine

• Registration Number: NCT01293149
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Study Start: 2011-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine plus clonidine	Clonidine	Ropivacaine plus clonidine for femoral block
Ropivacaine	Ropivacaine	Ropivacaine alone for femoral block

Primary Outcome Measures

Name	Time	Method
Pain	24 hours	The primary end-point of the study is time from performance of femoral nerve block to onset of pain in the distribution of the femoral nerve.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	15, 30 & 60 mins. post-op
Oxygen saturation	15, 30 & 60 mins. post-op
Heart rate	15, 30 & 60 mins. post-op

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States