Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: TAP block; Drug: wound infiltration

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bon-Wook Koo, Dr.; Phone Number: +82-10-7227-1379; Email: tendong2@gmail.com

Study Locations

• Korea, Republic of
  • Gyonggido
    • Seongnam-si, Gyonggido, Korea, Republic of
      • Recruiting
      • Seoul National Universuty, Bundang Hospital
      • Contact: Bon-Wook Koo, MD; Phone Number: +82-10-7227-1379; Email: tendong2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA class I-II
• Age: >18

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block; USG guided TAP block	Drug: TAP block; TAP block: local anesthetics infiltration at trans abdominis plane; Other Names: TAP
Active Comparator: wound infiltration; local anesthetics infiltration at surgical incision site	Drug: wound infiltration; wound infiltration: local anesthetics infiltration at surgical incision; Other Names: Wound

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: Jung-hi Ryu, Dr., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Estimated): December 28, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SNUBHTAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes