Bilateral RSB vs TEA Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy: A Randomized Controlled Trial
Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy
1 other identifier
interventional
60
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
June 9, 2026
CompletedJune 9, 2026
June 1, 2026
3 years
May 13, 2026
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Assessment
VAS
12 weeks
Secondary Outcomes (4)
Postoperative Recovery
12 weeks
Rescue Pain Management and Analgesia
12 weeks
Postoperative recovery
12 weeks
Opioids
12 weeks
Study Arms (2)
VAS
EXPERIMENTALVisual analog scale
Postoperative recovery
ACTIVE COMPARATORDays
Interventions
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.
Eligibility Criteria
You may qualify if:
- (ASA) Grades I to III.
- all adult patients (≥18 years) scheduled for elective open gastrectomy
You may not qualify if:
- those requiring acute gastric surgery,
- individuals with known bupivacaine allergies
- and patients who declined analgesia via RSB catheters and continuous bupivacaine infusions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Igors Ivanovslead
Study Sites (1)
Riga East Clinical University Hospital
Riga, Riga, 1039, Latvia
Related Publications (1)
Opincans J, Ivanovs I, Miscuks A, Pavulans J, Zemite E, Rudzats A, Kecbaja Z, Kaminskis A. Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2025 Sep 18;61(9):1695. doi: 10.3390/medicina61091695.
PMID: 41011085RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD, Professor
Study Record Dates
First Submitted
May 13, 2026
First Posted
June 9, 2026
Study Start
October 1, 2021
Primary Completion
October 1, 2024
Study Completion
October 1, 2025
Last Updated
June 9, 2026
Record last verified: 2026-06