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Clonidine in Femoral Nerve Block Surgery in Children

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293149
First Posted: February 10, 2011
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nationwide Children's Hospital
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain [ Time Frame: 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 [ Time Frame: 15, 30 & 60 mins. post-op ]
  • Blood pressure [ Time Frame: 15, 30 & 60 mins. post-op ]
  • Oxygen saturation [ Time Frame: 15, 30 & 60 mins. post-op ]

Enrollment: 0
Study Start Date: April 2011
Study Completion Date: March 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293149


Locations
United States, Ohio
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
  More Information

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
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: May 8, 2015
Last Verified: May 2015

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

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