Bilateral RSB vs TEA Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy: A Randomized Controlled Trial

June 2, 2026 updated by: Igors Ivanovs

Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy

Patients indicated for elective open gastrectomy were screened, enrolled, and randomised between October 2021 and September 2023. The patients were randomised to either Group A (intervention-continuous bupivacaine) or Group B (control-NaCl saline). The primary outcome measures were the quantity of an opioid analgesic administered during the initial 72 h post-surgery and the level of postoperative pain as indicated by the visual analogue scale (VAS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
    • Riga
      • Riga, Riga, Latvia, 1039
        • Riga East Clinical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (ASA) Grades I to III.
  • all adult patients (≥18 years) scheduled for elective open gastrectomy

Exclusion Criteria:

  • those requiring acute gastric surgery,
  • individuals with known bupivacaine allergies
  • and patients who declined analgesia via RSB catheters and continuous bupivacaine infusions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VAS
Visual analog scale
Procedure: Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.
The surgical procedure involved an upper middle laparotomy. Prior to the surgery, standard preoperative monitoring was conducted, including venous access placement, pulse oximetry, electrocardiography, and automated non-invasive arterial blood pressure measurement. General anesthesia was administered through both intravenous and endotracheal methods following standard protocols.
Active Comparator: Postoperative recovery
Days
Procedure: Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.
The surgical procedure involved an upper middle laparotomy. Prior to the surgery, standard preoperative monitoring was conducted, including venous access placement, pulse oximetry, electrocardiography, and automated non-invasive arterial blood pressure measurement. General anesthesia was administered through both intravenous and endotracheal methods following standard protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Assessment
Time Frame: 12 weeks
VAS
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Recovery
Time Frame: 12 weeks
Postoperative bowel movement
12 weeks
Rescue Pain Management and Analgesia
Time Frame: 12 weeks
Use of additional NSAIDs
12 weeks
Postoperative recovery
Time Frame: 12 weeks
Postoperative days
12 weeks
Opioids
Time Frame: 12 weeks
Use of opioids postoperatively
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igors Ivanovs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Publish study in Journal "Medicina" MDPI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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