Clonidine in Femoral Nerve Block Surgery in Children
The Effects of Clonidine on Postoperative Analgesia After Single Shot Femoral Nerve Block Following Arthroscopic Knee Surgery in Children
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2011
1 active site
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 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 8, 2015
May 1, 2015
1.9 years
February 9, 2011
May 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
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.
24 hours
Secondary Outcomes (3)
Heart rate
15, 30 & 60 mins. post-op
Blood pressure
15, 30 & 60 mins. post-op
Oxygen saturation
15, 30 & 60 mins. post-op
Study Arms (2)
Ropivacaine plus clonidine
EXPERIMENTALRopivacaine plus clonidine for femoral block
Ropivacaine
ACTIVE COMPARATORRopivacaine alone for femoral block
Interventions
clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologist (ASA) functional status I or II
- Patients scheduled for arthroscopic knee surgery only
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amod Sawardekar, MD
Nationwide Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 8, 2015
Record last verified: 2015-05