Dexmedetomidine and Bupivacaine With Bupivacaine in Ultra... | NCT02658760

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

NCT02658760

Sponsor

Hamidreza Mahboobi

Status

Unknown status

Last Update Posted

Oct 13, 2016Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Femoral Fractures

Interventions

Dexmedetomidine
Bupivacaine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jan 15, 2016

First Submission Date that Met QC Criteria

Jan 15, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hamidreza Mahboobi, Investigator, Hormozgan University of Medical SciencesSponsor-Investigator

Lead Sponsor

Hamidreza MahboobiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupivacaine	Experimental	30cc of 0.25% bupivacaine	Drug: Bupivacaine
Dexmedetomidine and bupivacaine	Active Comparator	30cc of 0.25% bupivacaine and 2mg/kg dexmedetomidine	Drug: Dexmedetomidine Drug: Bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	dexmedetomidine plus placebo	Dexmedetomidine and bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain	A point between 0 and 10 based on patient report	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Respiratory depression	respiratory rate < 12/min	24 hours
Hypotension	Systolic blood pressure < 90 mmHg	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with femural fracture

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hamidreza Mahboobi	Contact	9172121995	+98	hamidrezamahboobi@yahoo.com

Overall Officials

Name	Affiliation	Role
Nasim Abdi	Hormozgan University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid Mohammadi hospital	Recruiting	Bandar Abbas	Hormozgan	79176	Iran

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided