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Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults

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.
 
ClinicalTrials.gov Identifier: NCT02658760
Recruitment Status : Unknown
Verified October 2016 by Hamidreza Mahboobi, Hormozgan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hamidreza Mahboobi, Hormozgan University of Medical Sciences

Brief Summary:
Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.

Condition or disease Intervention/treatment Phase
Femoral Fractures Drug: Dexmedetomidine Drug: Bupivacaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Dexmedetomidine and Bupivacaine With Bupivacaine Alone on the Quality of Ultrasonography Guided Fascia Iliaca Compartment Block in Adults Undergoing Femur Fracture Fixation Surgery
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bupivacaine
30cc of 0.25% bupivacaine
Drug: Bupivacaine
dexmedetomidine and Bupivacaine

Active Comparator: Dexmedetomidine and bupivacaine
30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine
Drug: Dexmedetomidine
dexmedetomidine plus placebo

Drug: Bupivacaine
dexmedetomidine and Bupivacaine




Primary Outcome Measures :
  1. Pain [ Time Frame: 24 hours ]
    A point between 0 and 10 based on patient report


Secondary Outcome Measures :
  1. Respiratory depression [ Time Frame: 24 hours ]
    respiratory rate < 12/min

  2. Hypotension [ Time Frame: 24 hours ]
    Systolic blood pressure < 90 mmHg

  3. Baradycardia [ Time Frame: 24 hours ]
    Heart rate < 60/min



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with femural fracture

Exclusion Criteria:

  • Hypersensitivity to drugs
  • Neurological diseases
  • Coagulation abnormalities
  • Infection at the site of block

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): NCT02658760


Contacts
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Contact: Hamidreza Mahboobi 9172121995 ext +98 hamidrezamahboobi@yahoo.com

Locations
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Iran, Islamic Republic of
Shahid Mohammadi hospital Recruiting
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79176
Contact: Hamidreza Mahboobi    09809364300250    hamidrezamahboobi@yahoo.com   
Principal Investigator: Hamidreza Mahboobi         
Sponsors and Collaborators
Hamidreza Mahboobi
Investigators
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Principal Investigator: Nasim Abdi Hormozgan University of Medical Sciences
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Responsible Party: Hamidreza Mahboobi, Investigator, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02658760    
Other Study ID Numbers: Hums.Rec.1394.74
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hamidreza Mahboobi, Hormozgan University of Medical Sciences:
Femoral Fractures
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries
Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action