Combined Subcostal and Lateral Transversus Abdominis Plane Block for Postoperative Analgesia Versus Thoracic Epidural Analgesia in Patients Undergoing Major Abdominal Cancer Surgery

Safety and Efficacy of Combined Subcostal and Lateral Transversus Abdominis Plane Block for Postoperative Analgesia Versus Thoracic Epidural Analgesia in Patients Undergoing Major Abdominal Cancer Surgery

This study aims to evaluate the safety and efficacy of combined subcostal and lateral transversus abdominis plane (TAP) for postoperative analgesia versus thoracic epidural anesthesia (TEA) in patients undergoing major abdominal cancer surgery.

Study Overview

• Status: Recruiting
• Conditions: Transversus Abdominis Plane Block; Postoperative Analgesia; Thoracic Epidural Analgesia; Subcostal; Lateral; Major Abdominal Cancer Surgery
• Intervention / Treatment: Other: Subcostal and lateral transversus abdominis plane block; Other: Thoracic epidural anesthesia

Detailed Description

Postoperative pain is treated using a variety of techniques. It is possible to deliver opioids intravenously, neuraxially, or both.

Thoracic epidural anesthesia (TEA) has long been considered the benchmark for analgesia in major abdominal operations due to its consistent efficacy in pain control and additional benefits such as reduced ileus and improved pulmonary function.

Transversus abdominis plane (TAP) blocks can be a critical component of postoperative pain management, and they play a crucial role in Enhanced Recovery After Surgery (ERAS) protocols, as they significantly affect recovery and patient well-being.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bahaa G Saad, MD; Phone Number: 00201555590977; Email: bahaagamal@aun.edu.eg

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Recruiting
    • Assiut University
    • Contact: Bahaa G Saad, MD; Phone Number: 00201555590977; Email: bahaagamal@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Scheduled for major abdominal surgeries including: (e.g., gastrectomy, colectomy, hepatectomy, cystectomy, total abdominal hysterectomy, Nephrectomy, pancreatectomy).

Exclusion Criteria:

• Intraoperative hemodynamic instability.
• History or evidence of coagulopathy.
• Infection or abdominal wall masses at injection site.
• Morbid obesity.
• Other Medical conditions including mental illness or substance abuse.
• Known allergy to local anesthetics.
• Chronic opioid use or chronic pain conditions.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcostal and lateral transversus abdominis plane block group; Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block.	Other: Subcostal and lateral transversus abdominis plane block; Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block.
Active Comparator: Thoracic epidural anesthesia group; Patients will receive an ultrasound-guided thoracic epidural anesthesia.	Other: Thoracic epidural anesthesia; Patients will receive an ultrasound-guided thoracic epidural anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS) > 3 to be repeated after 30 min if pain persists until the VAS < 4.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication.	24 hours postoperatively
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).	24 hours postoperatively
Mean arterial pressure	Mean arterial pressure will be recorded before skin incision, one minute after skin incision and then recorded regularly every 10 minutes.	Till the end of surgery (Up to 2 hours)
Heart rate	Heart rate will be recorded before skin incision, one minute after skin incision and then recorded regularly every 10 minutes.	Till the end of surgery (Up to 2 hours)
Degree of pain	Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 6, 8, 12, and 24 h postoperatively.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 620 (GCRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No