Effect of the Addition of Dexmedetomidine to Bupivacaine... | NCT02049970

Studies
Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade

NCT02049970

Sponsor

TC Erciyes University

Status

Completed

Last Update Posted

Nov 10, 2014Estimated

Enrollment

44Actual

Phase

Phase 4

Conditions

Sequelae of Fracture of Forearm and Upper Arm

Interventions

dexmedetomidine
bupivacaine

Countries

Turkey (Türkiye)

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Jan 28, 2014

First Submission Date that Met QC Criteria

Jan 28, 2014

First Posted Date

Jan 30, 2014Estimated

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

Nov 7, 2014

Last Update Posted Date

Nov 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

the aim of this study was effect of the addition of dexmedetomidine to bupivacaine during supraclavicular brachial plexus blockade for forearm surgery, by low doses bupivacaine providing prolonged analgesia after surgery.

Detailed Description

Anaesthesia for surgeries to the upper extremity commonly is provided using brachial plexus anaesthesia.Various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexmedetomidine are frequently used for this purpose. this study was conducted to compare the effects of adding dexmedetomidine to local anaesthetics in the supraclavicular brachial plexus block by using nerve stimulators and ultrasonography guided. dexmedetomidine has also been found the prolong the duration of bupivacaine infraclavicular brachial plexus block.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dexmedetomidine and bupivacaine	Experimental	Bupivacaine 50 mg and dexmedetomidine 1 microgram/kg	Drug: dexmedetomidine Drug: bupivacaine
Bupivacaine and placebo	Experimental	Bupivacaine 100 mg and SF 10 ml	Drug: dexmedetomidine Drug: bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexmedetomidine	Drug	1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus	Bupivacaine and placebo dexmedetomidine and bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the duration of sensorial block	pin-prick test	postoperative 1 day

Secondary Outcomes

Measure	Description	Time Frame
the first time analgesic required		postoperative 1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 age
unwanted general anaesthesia
ASA 1-2
single forearm, arm surgery

Exclusion Criteria:

major psychiatric problems
major neurologic deficits
coagulopathy
drug allergies
chronic analgesic used

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Recep Aksu	Ass.Prof.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erciyes University Medical Faculty		Kayseri		38039	Turkey (Türkiye)

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