Clonidine in Femoral Nerve Block Surgery in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Nationwide Children's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01293149
First received: February 9, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention Phase
Other Reconstructive Surgery
Drug: Ropivacaine
Drug: Clonidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15, 30 & 60 mins. post-op ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 15, 30 & 60 mins. post-op ] [ Designated as safety issue: Yes ]
  • Oxygen saturation [ Time Frame: 15, 30 & 60 mins. post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293149

Contacts
Contact: Julie Rice, RN, BSN, CCRC 614-355-3142 Julie.Rice@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Amod Sawardekar, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Amod Sawardekar, MD/ Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01293149     History of Changes
Other Study ID Numbers: IRB11-00075
Study First Received: February 9, 2011
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
knee, reconstructive surgery
femoral nerve block

Additional relevant MeSH terms:
Clonidine
Ropivacaine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 23, 2014