NCT07273136

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 27, 2025

Last Update Submit

December 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Time to the 1st rescue analgesia

    24 hours postoperatively

  • Mean arterial pressure

    Till the end of surgery (Up to 2 hours)

  • Heart rate

    Till the end of surgery (Up to 2 hours)

  • Degree of pain

    24 hours postoperatively

  • Incidence of adverse events

    24 hours postoperatively

Study Arms (2)

Subcostal and lateral transversus abdominis plane block group

EXPERIMENTAL

Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block.

Other: Subcostal and lateral transversus abdominis plane block

Thoracic epidural anesthesia group

ACTIVE COMPARATOR

Patients will receive an ultrasound-guided thoracic epidural anesthesia.

Other: Thoracic epidural anesthesia

Interventions

Patients will receive an ultrasound-guided thoracic epidural anesthesia.

Thoracic epidural anesthesia group

Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block.

Subcostal and lateral transversus abdominis plane block group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 9, 2025

Study Start

December 10, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations