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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02658760
Other study ID # Hums.Rec.1394.74
Secondary ID
Status Recruiting
Phase Phase 3
First received January 15, 2016
Last updated October 12, 2016
Start date June 2015
Est. completion date December 2016

Study information

Verified date October 2016
Source Hormozgan University of Medical Sciences
Contact Hamidreza Mahboobi
Phone 9172121995
Email hamidrezamahboobi@yahoo.com
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 14 Years and older
Eligibility Inclusion Criteria:

- Adults with femural fracture

Exclusion Criteria:

- Hypersensitivity to drugs

- Neurological diseases

- Coagulation abnormalities

- Infection at the site of block

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
dexmedetomidine plus placebo
Bupivacaine
dexmedetomidine and Bupivacaine

Locations

Country Name City State
Iran, Islamic Republic of Shahid Mohammadi hospital Bandar Abbas Hormozgan

Sponsors (1)

Lead Sponsor Collaborator
Hamidreza Mahboobi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain A point between 0 and 10 based on patient report 24 hours No
Secondary Respiratory depression respiratory rate < 12/min 24 hours Yes
Secondary Hypotension Systolic blood pressure < 90 mmHg 24 hours Yes
Secondary Baradycardia Heart rate < 60/min 24 hours Yes
See also
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Completed NCT03822000 - Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture
Completed NCT06382584 - Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur
Completed NCT05172869 - Comparison of Two Different Approaches in the Fascia Iliaca Compartment Block in Femoral Fracture Surgery N/A
Terminated NCT01294098 - Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture N/A