Postoperative Analgesic Effects of Using Dexmedetomidine... | NCT02544893

Studies
Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block

NCT02544893

Sponsor

TC Erciyes University

Status

Completed

Last Update Posted

Aug 3, 2016Estimated

Enrollment

93Actual

Phase

Phase 4

Conditions

Pain

Interventions

bupivacaine
dexmedetomidin
serum physiologic

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

Aug 2016

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

Sep 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Sep 7, 2015

First Submission Date that Met QC Criteria

Sep 7, 2015

First Posted Date

Sep 9, 2015Estimated

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

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

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

we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy

Detailed Description

paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

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

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bupivacaine	Active Comparator	0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on paravertebral block	Drug: bupivacaine
dexmedetomidine	Active Comparator	100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on paravertebral block	Drug: dexmedetomidin
serum phsyologic	Active Comparator	0,9% 21 ml serum physiologic	Drug: serum physiologic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine	Drug	21 ml 0.5 %bupivacaine is applied paravertebral space	bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
opioid consumption	patient controlled analgesia	postoperative 24 hours

Secondary Outcomes

Measure	Description	Time Frame
visual analog scale	visual analog scale	postoperative 1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1-2
18-65 aged
patient undergoing thoracotomy

Exclusion Criteria:

chronic opioid consumption
bupivacaine and dexmedetomidine allergies
coagulopathy
infection at the needle insertion side
chronic liver and kidney disease

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
esra n ünalan, resident	TC Erciyes University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erciyes University Medicine Faculty		Kayseri		38080	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided