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Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

Primary Purpose

Pain, Postoperative

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TAP block

wound infiltration

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ASA class I-II
Age: >18

Exclusion Criteria:

patients of severe kidney & liver dysfunction
allergy of local anesthetics

Sites / Locations

Seoul National Universuty, Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP block

wound infiltration

Arm Description

USG guided TAP block

local anesthetics infiltration at surgical incision site

Outcomes

Primary Outcome Measures

post operative pain score

100 mm scale of visual analogue scale

Secondary Outcome Measures

post operative opioid consumption

total amount of opioid

Full Information

NCT ID

NCT03805269

First Posted

January 12, 2019

Last Updated

April 23, 2021

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03805269

Brief Title

Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

Official Title

Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 14, 2019 (Actual)

Primary Completion Date

December 28, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TAP block

Arm Type

Experimental

Arm Description

USG guided TAP block

Arm Title

wound infiltration

Arm Type

Active Comparator

Arm Description

local anesthetics infiltration at surgical incision site

Intervention Type

Drug

Intervention Name(s)

TAP block

Other Intervention Name(s)

TAP

Intervention Description

TAP block: local anesthetics infiltration at trans abdominis plane

Intervention Type

Drug

Intervention Name(s)

wound infiltration

Other Intervention Name(s)

Wound

Intervention Description

wound infiltration: local anesthetics infiltration at surgical incision

Primary Outcome Measure Information:

Title

post operative pain score

Description

100 mm scale of visual analogue scale

Time Frame

4 hours after end of surgery

Secondary Outcome Measure Information:

Title

post operative opioid consumption

Description

total amount of opioid

Time Frame

4 hours after end of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA class I-II Age: >18 Exclusion Criteria: patients of severe kidney & liver dysfunction allergy of local anesthetics

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bon-Wook Koo, Dr.

Phone

+82-10-7227-1379

tendong2@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung-hi Ryu, Dr.

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National Universuty, Bundang Hospital

City

Seongnam-si

State/Province

Gyonggido

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bon-Wook Koo, MD

Phone

+82-10-7227-1379

tendong2@gmail.com

12. IPD Sharing Statement

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Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

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