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Effect of Intravenous Dexmedetomidine on Analgesic Duration of Infraclavicular Block

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ClinicalTrials.gov Identifier: NCT01981369
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The study will evaluate the effect of Dexmedetomidine sedation on the duration of infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All patients will receive infraclavicular block before the surgery and then they will be randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory block will be evaluated in recovery room, 24 and 48 hours after the surgery.

Hypothesis:

Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in patients scheduled for upper limb surgery.

Secondary: Dexmedetomidine sedation

  • Gives an adequate level of sedation during the surgical procedure
  • Reduces the requirements of postoperative opioids
  • Improves the quality of sleep on the night of the surgery
  • Increases patients satisfaction regarding the anesthesia technique
  • Dexmedetomidine sedation is safe and easy to use
  • Dexmedetomidine sedation provides less respiratory depression during the procedure.

Condition or disease Intervention/treatment
Postoperative Pain Drug: Dexmedetomidine Drug: Propofol Procedure: Infraclavicular block

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Dexmedetomidine on the Analgesic Duration of Infraclavicular Block With Ropivacaine for Upper Limb Surgery: a Prospective, Randomized, Double Blind Study
Actual Study Start Date : January 2014
Primary Completion Date : July 2016
Study Completion Date : December 2016

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Propofol sedation.
This group will have infraclavicular block and sedation during surgery with intravenous Propofol. Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery.
Drug: Propofol
Intravenous sedation with propofol
Procedure: Infraclavicular block
All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital.
Experimental: Dexmedetomidine sedation.
This group will have infraclavicular block and sedation with intravenous Dexmedetomidine. Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery.
Drug: Dexmedetomidine
Intravenous sedation with dexmedetomidine
Other Name: Precedex
Procedure: Infraclavicular block
All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital.


Outcome Measures

Primary Outcome Measures :
  1. The duration of sensory infraclavicular block in patients scheduled for upper limb surgery. [ Time Frame: The primary outcome will be the duration of the sensory infraclavicular block in minutes, from the moment that the block is perfomed and the moment of first analgesic request. ]
    In the data collection form will be record the time of performance of the infraclavicular block. The patients will have a diary where they will record the time of the day when day have the first analgesic request because of pain in the surgical site.


Eligibility Criteria

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and females of 16-80 years of age, scheduled for hand, forearm and elbow ambulatory surgery with an infraclavicular block.
  • American Society of Anesthesiologist (ASA) Class I, II, III
  • Ability to cooperate with study related procedures

Exclusion Criteria:

  • ASA IV
  • Narcotic dependent (opioid intake more than 3 months) or chronic pain conditions
  • Associated significant cardiac or respiratory disease, neurological deficits
  • Coexisting hematological disorder or with deranged coagulation
  • Pre-existing major organ dysfunction
  • Psychiatric illnesses
  • Emergency surgery
  • Lack of informed consent
  • Allergy to any of the drugs used in the study
  • Surgical procedure duration greater than 3 hours
Contacts and Locations

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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): NCT01981369


Locations
Canada, Ontario
Saint Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shalini Dhir, MD, FRCPC Lawson Health Research Institute & Western University
More Information

Responsible Party: Shalini Dhir, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01981369     History of Changes
Other Study ID Numbers: 104572
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Shalini Dhir, Lawson Health Research Institute:
Dexmedetomidine sedation
Regional Anesthesia
Infraclavicular block

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Propofol
Dexmedetomidine
Analgesics
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action