NCT03805269

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

5.8 years

First QC Date

January 12, 2019

Last Update Submit

January 11, 2024

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • post operative pain score

    100 mm scale of visual analogue scale

    4 hours after end of surgery

Secondary Outcomes (1)

  • post operative opioid consumption

    4 hours after end of surgery

Study Arms (2)

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

TAP blockDRUG

TAP block: local anesthetics infiltration at trans abdominis plane

Also known as: TAP
TAP block
wound infiltrationDRUG

wound infiltration: local anesthetics infiltration at surgical incision

Also known as: Wound
wound infiltration

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-II
  • Age: \>18

You may not qualify if:

  • patients of severe kidney \& liver dysfunction
  • allergy of local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Universuty, Bundang Hospital

Seongnam-si, Gyonggido, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jung-hi Ryu, Dr.

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Bon-Wook Koo, Dr.

CONTACT

+82-10-7227-1379tendong2@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asociative professor

Study Record Dates

First Submitted

January 12, 2019

First Posted

January 15, 2019

Study Start

March 14, 2019

Primary Completion

December 28, 2024

Study Completion

December 31, 2024

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations

KR(1)