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

Femoral Fractures Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02658760
• Other study ID #: Hums.Rec.1394.74
• 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

• Femoral Fractures
• Fractures, Bone

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