SubcostalNCT07273136
Combined Subcostal and Lateral Transversus Abdominis Plane Block for Postoperative Analgesia Versus Thoracic Epidural Analgesia in Patients Undergoing Major Abdominal Cancer Surgery
A study testing Subcostal and lateral transversus abdominis plane block and Thoracic epidural anesthesia in people with Subcostal and Lateral, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subcostal, Lateral, Transversus Abdominis Plane Block
- What is being tested?
- Subcostal and lateral transversus abdominis plane block and Thoracic epidural anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Bahaa G Saad, MD, 00201555590977, bahaagamal@aun.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Subcostal, Lateral, Transversus Abdominis Plane Block, Postoperative Analgesia, Thoracic Epidural Analgesia, Major Abdominal Cancer Surgery
- Being tested
- Subcostal and lateral transversus abdominis plane block, Thoracic epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal and lateral transversus abdominis plane blockOther
Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block.
Thoracic epidural anesthesiaOther
Patients will receive an ultrasound-guided thoracic epidural anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Subcostal and lateral transversus abdominis plane block group | Experimental | Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block. Receives: Other: Subcostal and lateral transversus abdominis plane block |
| Thoracic epidural anesthesia group | Active comparator | Patients will receive an ultrasound-guided thoracic epidural anesthesia. Receives: Other: Thoracic epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start10 Dec 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubcostalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Gamal Saad Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273136
- Sponsor's protocol ID
- 620
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07273136
- Acronym / sponsor ID
- 620
- Conditions
- Subcostal, Lateral, Transversus Abdominis Plane Block, Postoperative Analgesia, Thoracic Epidural Analgesia, Major Abdominal Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcostal and lateral transversus abdominis plane block group | Experimental | Other: Subcostal and lateral transversus abdominis plane blockPatients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block. |
| Thoracic epidural anesthesia group | Active comparator | Other: Thoracic epidural anesthesiaPatients will receive an ultrasound-guided thoracic epidural anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcostal and lateral transversus abdominis plane blockPatients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block. | Other | Subcostal and lateral transversus abdominis plane block group |
| Thoracic epidural anesthesiaPatients will receive an ultrasound-guided thoracic epidural anesthesia. | Other | Thoracic epidural anesthesia group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
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.
5 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Mean arterial pressure
Time frame: Till the end of surgery (Up to 2 hours)
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Degree of pain
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal and lateral transversus abdominis plane block and Thoracic epidural anesthesia in people with Subcostal and Lateral, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahaa G Saad, MD (00201555590977, bahaagamal@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.