Postoperative Analgesic Effects of Dexmedetomidine for Tr... | NCT02064530

Studies
Postoperative Analgesic Effects of Dexmedetomidine for Transversus Abdominis Plane Block

NCT02064530

Sponsor

TC Erciyes University

Status

Completed

Last Update Posted

Sep 14, 2015Estimated

Enrollment

90Estimated

Phase

Phase 4

Conditions

Pain

Interventions

Bupivacaine
Dexmedetomidine
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

Sep 2015

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

Feb 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 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

Sep 11, 2015

Last Update Posted Date

Sep 14, 2015Estimated

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 is evaluate postoperative analgesic effects of dexmedetomidine added to bupivacaine on TAP block in patients undergoing lower abdominal surgery.

Detailed Description

TAP block is being used a method of multimodal balanced analgesia reduces postoperative pain, opioid requirement after surgery and adverse effect of opioid such as sedation, nausea vomiting and ileus. 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

90Estimated

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 TAP block	Drug: Bupivacaine
dexmedetomidine	Active Comparator	100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on TAP block	Drug: Dexmedetomidine
serum phsyologic	Sham 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 interfasially	bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
opioid consumption	patient controlled analgesia	postoperative 1 day

Secondary Outcomes

Measure	Description	Time Frame
visual analog scale		postoperative 1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 1-2
18-65 aged
patient undergoing lower abdominal surgery

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
Recep Aksu, assoc. prof.	Erciyes universty medicine faculty	Study Director
Gülçin Patmano, resident	Erciyes universty medicine faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erciyes universty		Kayseri	Melikgazi	38039	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