NCT02658760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

January 15, 2016

Last Update Submit

October 12, 2016

Conditions

Femoral Fractures

Keywords

Femoral Fractures

Outcome Measures

Primary Outcomes (1)

  • Pain

    A point between 0 and 10 based on patient report

    24 hours

Secondary Outcomes (3)

  • Respiratory depression

    24 hours

  • Hypotension

    24 hours

  • Baradycardia

    24 hours

Study Arms (2)

Bupivacaine

EXPERIMENTAL

30cc of 0.25% bupivacaine

Drug: Bupivacaine

Dexmedetomidine and bupivacaine

ACTIVE COMPARATOR

30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine

Drug: DexmedetomidineDrug: Bupivacaine

Interventions

DexmedetomidineDRUG

dexmedetomidine plus placebo

Dexmedetomidine and bupivacaine
BupivacaineDRUG

dexmedetomidine and Bupivacaine

BupivacaineDexmedetomidine and bupivacaine

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with femural fracture

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Interventions

DexmedetomidineBupivacaine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nasim Abdi

    Hormozgan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamidreza Mahboobi

CONTACT

9172121995hamidrezamahboobi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)