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

Phase 3

• Conditions: Femoral Fractures
• Interventions: Drug: Bupivacaine; Drug: Dexmedetomidine

• Registration Number: NCT02658760
• Lead Sponsor: Hamidreza Mahboobi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults with femural fracture

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	30cc of 0.25% bupivacaine
Dexmedetomidine and bupivacaine	Dexmedetomidine	30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine
Dexmedetomidine and bupivacaine	Bupivacaine	30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Pain	24 hours	A point between 0 and 10 based on patient report

Secondary Outcome Measures

Name	Time	Method
Respiratory depression	24 hours	respiratory rate \< 12/min
Hypotension	24 hours	Systolic blood pressure \< 90 mmHg
Baradycardia	24 hours	Heart rate \< 60/min

Trial Locations

Locations (1)

Shahid Mohammadi hospital; 🇮🇷 Bandar Abbas, Hormozgan, Iran, Islamic Republic of