UltrasoundNCT07324863
Ultrasound Guided External Oblique and Rectus Abdominis Plane Block (EXORA) on Neuroendocrine Stress Response in Adults Undergoing Umbilical Hernia Surgery
A study testing General anesthesia and External oblique and rectus abdominis plane (EXORA) block in people with Ultrasound and External Oblique, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of ultrasound-guided external oblique and rectus abdominis plane block on the neuroendocrine stress response and postoperative analgesia in adults undergoing umbilical hernia repair. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Ultrasound, External Oblique, Rectus Abdominis Plane Block
- What is being tested?
- General anesthesia and External oblique and rectus abdominis plane (EXORA) block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Sep 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical status I and Ⅱ.
- Schedule for elective umbilical hernia surgery under general anesthesia.
Who cannot join
- ASA Ⅲ or Ⅳ.
- Patients with metabolic abnormalities, e.g., diabetes mellitus.
- Patients receiving corticosteroids.
- History of allergies to local anesthetics.
- Bleeding or coagulation disorders.
- Anatomical abnormalities.
Show all 9Show fewer
- Psychiatric and neurological disorders.
- Complicated hernial defect (obstructed).
- Patient refusal.
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
Tanta University
Tanta, 31527
Mayada H Sokeer, Master, 00201095315597, mayada.hady@med.tanta.edu.eg
Lobna M Khalil, MD
About this study
Official title: The Effect of Ultrasound Guided External Oblique and Rectus Abdominis Plane Block (EXORA) on Neuroendocrine Stress Response in Adults Undergoing Umbilical Hernia Surgery: A Prospective Randomized Controlled Trial
This study aims to evaluate the efficacy of ultrasound-guided external oblique and rectus abdominis plane block on the neuroendocrine stress response and postoperative analgesia in adults undergoing umbilical hernia repair.
Read the detailed description
Umbilical hernias of the abdomen are defined as a non-inguinal, non-hiatal defect in the fascia of the abdominal wall. Surgical stress response refers to the physiologic response to surgery and the hormonal and metabolic changes that follow it.
Fascial plane blocks are gaining attention for perioperative analgesia due to their efficacy and safety profiles. The external oblique and rectus abdominis plane (EXORA) block is an emerging technique that provides a sensory block to the anterolateral abdominal wall, potentially filling gaps left by other commonly used blocks, such as the quadratus lumborum (QLB) or erector spinae plane (ESP) blocks.
- Conditions
- Ultrasound, External Oblique, Rectus Abdominis Plane Block, Neuroendocrine Stress Response, Umbilical Hernia
- Being tested
- General anesthesia, External oblique and rectus abdominis plane (EXORA) block
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaOther
Patients will receive general anesthesia only.
External oblique and rectus abdominis plane (EXORA) blockOther
Patients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive general anesthesia only. Receives: Other: General anesthesia |
| Group Ⅱ | Experimental | Patients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine. Receives: Other: External oblique and rectus abdominis plane (EXORA) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroendocrine stress response
Neuroendocrine stress response will be measured by blood glucose level in adults undergoing umbilical hernia repair.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Serum cortisol level
Serum cortisol level will be measured.
Measured: 24 hours postoperatively
Time of first rescue analgesia
Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administration.
Measured: 24 hours postoperatively
Total intraoperative fentanyl consumption
Rescue dose of intraoperative fentanyl given will be recorded.
Measured: Intraoperatively
Total morphine consumption
Intravenous morphine (rescue analgesic) at a dosage of 3 mg will be administered when the Numerical Rating Scale (NRS) score will be ≥ 4. The total morphine consumption over a 24-hours period will be recorded for these individuals.
Measured: 24 hours postoperatively
Degree of pain
Each patient will be instructed in postoperative pain assessment using the Numerical Rating Scale (NRS), ranging from 0 to 10 (0 = "no pain," 10 = "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU),1,2,4,6,12,24 hours postoperative
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 posted8 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayada Hady Mahmoud Sokeer, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324863
- Sponsor's protocol ID
- 36265MD474/10/25
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 8 Jan 2026
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound Guided External Oblique and Rectus Abdominis Plane Block (EXORA) on Neuroendocrine Stress Response in Adults Undergoing Umbilical Hernia Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07324863
- Acronym / sponsor ID
- 36265MD474/10/25
- Conditions
- Ultrasound, External Oblique, Rectus Abdominis Plane Block, Neuroendocrine Stress Response, Umbilical Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Jan 2026 (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 efficacy of ultrasound-guided external oblique and rectus abdominis plane block on the neuroendocrine stress response and postoperative analgesia in adults undergoing umbilical hernia repair.
Detailed description
Umbilical hernias of the abdomen are defined as a non-inguinal, non-hiatal defect in the fascia of the abdominal wall. Surgical stress response refers to the physiologic response to surgery and the hormonal and metabolic changes that follow it.
Fascial plane blocks are gaining attention for perioperative analgesia due to their efficacy and safety profiles. The external oblique and rectus abdominis plane (EXORA) block is an emerging technique that provides a sensory block to the anterolateral abdominal wall, potentially filling gaps left by other commonly used blocks, such as the quadratus lumborum (QLB) or erector spinae plane (ESP) blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: General anesthesiaPatients will receive general anesthesia only. |
| Group Ⅱ | Experimental | Other: External oblique and rectus abdominis plane (EXORA) blockPatients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical status I and Ⅱ.
- Schedule for elective umbilical hernia surgery under general anesthesia.
Key exclusion criteria (9 listed)
- ASA Ⅲ or Ⅳ.
- Patients with metabolic abnormalities, e.g., diabetes mellitus.
- Patients receiving corticosteroids.
- History of allergies to local anesthetics.
- Bleeding or coagulation disorders.
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 |
|---|---|---|
| General anesthesiaPatients will receive general anesthesia only. | Other | Group I |
| External oblique and rectus abdominis plane (EXORA) blockPatients will receive general anesthesia and an external oblique and rectus abdominis plane (EXORA) block with 0.25% bupivacaine. | Other | Group Ⅱ |
Primary outcome
Neuroendocrine stress response
Time frame: 24 hours postoperatively
Neuroendocrine stress response will be measured by blood glucose level in adults undergoing umbilical hernia repair.
5 secondary outcomes
Serum cortisol level
Time frame: 24 hours postoperatively
Time of first rescue analgesia
Time frame: 24 hours postoperatively
Total intraoperative fentanyl consumption
Time frame: Intraoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Degree of pain
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 8 Jan 2026.
- 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 General anesthesia and External oblique and rectus abdominis plane (EXORA) block in people with Ultrasound and External Oblique, run by Tanta 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 9 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 8 Jan 2026. 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 Mayada H Sokeer, Master (00201095315597, mayada.hady@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroendocrine stress response (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 8 Jan 2026.