Transversus Abdominis Plane(TAP) Block Versus Local Anest... | NCT03805269

Studies
Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

NCT03805269

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jan 16, 2024Actual

Enrollment

94Estimated

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

TAP block
wound infiltration

Countries

South Korea

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

Jan 2024

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

Mar 14, 2019Actual

Primary Completion Date

Dec 28, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 12, 2019

First Submission Date that Met QC Criteria

Jan 14, 2019

First Posted Date

Jan 15, 2019Actual

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

Jan 11, 2024

Last Update Posted Date

Jan 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

BON WOOK KOO, asociative professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy.

The purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.

Detailed Description

Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.

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

94Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP block	Experimental	USG guided TAP block	Drug: TAP block
wound infiltration	Active Comparator	local anesthetics infiltration at surgical incision site	Drug: wound infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAP block	Drug	TAP block: local anesthetics infiltration at trans abdominis plane	TAP block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post operative pain score	100 mm scale of visual analogue scale	4 hours after end of surgery

Secondary Outcomes

Measure	Description	Time Frame
post operative opioid consumption	total amount of opioid	4 hours after end of surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA class I-II
Age: >18

Exclusion Criteria:

patients of severe kidney & liver dysfunction
allergy of local anesthetics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bon-Wook Koo, Dr.	Contact	+82-10-7227-1379		tendong2@gmail.com

Overall Officials

Name	Affiliation	Role
Jung-hi Ryu, Dr.	Seoul National University Bundang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Universuty, Bundang Hospital	Recruiting	Seongnam-si	Gyonggido		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided