Paragastric Neural Blockade and Laparoscopic Assisted Transversus Abdominis Plane Block on Visceral Pain After Surgery

NCT06973122 | Recruiting DMC

• 1 other identifier: 0307254
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

after laparoscopic bariatric surgery, visceral pain (VP) remains a significant issue. VP causes autonomic symptoms, such as nausea and vomiting, and does not respond to conventional pain management methods that target incisional pain. The present study was performed to test the effect of use of combined paragastric autonomic neural blockade and laparoscopic assisted transversus abdominis plane block on visceral pain during laparoscopic bariatric surgery and in the early postoperative period.

Conditions

Visceral Pain

Keywords

paragastric; bariatric surgery; visceral pain

Outcome Measures

Primary Outcomes (1)

• postoperative pain score

  VAS score

  postoperative day 1

Secondary Outcomes (3)

• Number of patients who need opioids in postoperative period

  postoperative day 1

• time to first dose of rescue analgesia

  postoperative day1

• Postoperative nausea and vomiting

  postoperative day 1

Study Arms (2)

Paragastric and transversus abdominis plane block

EXPERIMENTAL

patients will undergo laparoscopic bariatric surgery under general anesthesia, paragastric autonomic neural blockade and laparoscopic assisted transversus abdominis plane block

Procedure: combined paragastric autonomic neural blockade and laparoscopic assisted transversus abdominis plane block

Transversus abdominis plane block

OTHER

patients will undergo laparoscopic bariatric surgery under general anesthesia and laparoscopic assisted transversus abdominis plane block

Procedure: laparoscopic assisted transversus abdominis plane block

Interventions

combined paragastric autonomic neural blockade and laparoscopic assisted transversus abdominis plane block PROCEDURE

paragastric autonomic neural blockade and laparoscopic assisted transversus abdominis plane block

Also known as: group C

Paragastric and transversus abdominis plane block

laparoscopic assisted transversus abdominis plane block PROCEDURE

laparoscopic assisted transversus abdominis plane block

Also known as: group P

Transversus abdominis plane block

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-50 years, both sexes.
• ASA physical status class I to III.
• BMI 35- 50 kg/m²

You may not qualify if:

• Severe cardiac disorder
• chronic renal failure
• liver cirrhosis
• allergy to bupivacaine
• patients with history of chronic opioid consumption
• HBA1C \> 7%

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (1)

• Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.

  PMID: 36050617 BACKGROUND

MeSH Terms

Conditions

Visceral Pain

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sarah m elgamal, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sarah m elgamal, MD

CONTACT

01005496440; sarahelgamal1990@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 15, 2025
• Study Start: April 4, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)