Clonidine in Femoral Nerve Block Surgery in Children

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01293149

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Other Reconstructive Surgery	Drug: Ropivacaine Drug: Clonidine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Clonidine on Postoperative Analgesia After Single Shot Femoral Nerve Block Following Arthroscopic Knee Surgery in Children

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ropivacaine plus clonidine Ropivacaine plus clonidine for femoral block	Drug: Clonidine clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)
Active Comparator: Ropivacaine Ropivacaine alone for femoral block	Drug: Ropivacaine ropivacaine 0.2% 0.5 ml/kg (max 20 ml)

Arm

Intervention/Treatment

Experimental: Ropivacaine plus clonidine

Ropivacaine plus clonidine for femoral block

Drug: Clonidine

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

Active Comparator: Ropivacaine

Ropivacaine alone for femoral block

Drug: Ropivacaine

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

Outcome Measures

Primary Outcome Measures

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

Heart rate [15, 30 & 60 mins. post-op]
Blood pressure [15, 30 & 60 mins. post-op]
Oxygen saturation [15, 30 & 60 mins. post-op]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators

Principal Investigator: Amod Sawardekar, MD, Nationwide Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01293149

Other Study ID Numbers:

IRB11-00075

First Posted:

Feb 10, 2011

Last Update Posted:

May 8, 2015

Last Verified:

May 1, 2015

Keywords provided by , ,

knee, reconstructive surgery

femoral nerve block

Additional relevant MeSH terms:

Clonidine

Ropivacaine

Study Results

No Results Posted as of May 8, 2015