Postoperative PainEOINBNCT06056479
Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy
A study testing external oblique intercostal block in people with Postoperative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
The patients will be randomly allocated into two equal groups using a computer program. Group A: will receive external oblique intercostal block after induction. Group B: will receive postoperative morphine per patient request. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- external oblique intercostal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2023to 25 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Eligible patients will be older than 18 years old with American society of anestheologist ASA physical status I, II and III scheduled for Trans-Abdominal ( Anterior Subcostal) Nephrectomy
Who cannot join
- Patients who are:
- Unable to cooperate.
- Patients who have allergy to any of the study drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
- Local infection at the site of injection or systemic infection.
- Pregnancy
- Patients with coagulation disorders or on anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcostal Nephrectomy: A Randomised Trial
The patients will be randomly allocated into two equal groups using a computer program.
Group A: will receive external oblique intercostal block after induction. Group B: will receive postoperative morphine per patient request.
Read the detailed description
General anaesthesia induction will be achieved using fentanyl 1µg/kg (IV), propofol 2mg/kg (IV), and0.5mg/kg of IV Atracurium. General anaesthesia will be maintained with mechanical ventilation with isoflurane with O2 \ Air mixture.
During anaesthesia maintenance Intraoperatively, if BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine will be given to stabilize the patients' haemodynamics.
All patients will receive 1g intravenous paracetamol and 4mg ondansetron 8mg dexamethasone.
- Conditions
- Postoperative Pain
- Being tested
- external oblique intercostal block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external oblique intercostal blockProcedure or surgery
20 ml of bupivacaine 0.25% will be administered by US into external oblique intercostal plane at the level of sixth rib space .
| Study group | Role | What they receive |
|---|---|---|
| external oblique intercostal block after induction | Active comparator | After induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted.
Initially the probe is placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line with the xiphoid process. To confirm correct identification of the external oblique muscle, With 17gauge echogenic ultrasound needle will be advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle.30 ml of bupivacaine 0.25% will be administered incrementally. Receives: Procedure: external oblique intercostal block |
| postoperative morphine per patient request | No intervention | In this group no block will be done only morphine will be given intraoperatively- according to hemodynamic change and postoperative by morphine per patient request |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first rescue analgesia
hours
Measured: day 0
Secondary outcomes (2)
VAS score
1 to 10 (0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)
Measured: 24 hours
rescue analgesics
morphine mg
Measured: 24hous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start25 Sep 2023
- Primary completion10 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- AMAL G SAFAN, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056479
- Sponsor's protocol ID
- 9/2023ANET1-1
- Acronym
- EOINB
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcostal Nephrectomy: A Randomised Trial
- ClinicalTrials.gov ID
- NCT06056479
- Acronym / sponsor ID
- EOINB / 9/2023ANET1-1
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 28 Sep 2023 (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.
The patients will be randomly allocated into two equal groups using a computer program.
Group A: will receive external oblique intercostal block after induction. Group B: will receive postoperative morphine per patient request.
Detailed description
General anaesthesia induction will be achieved using fentanyl 1µg/kg (IV), propofol 2mg/kg (IV), and0.5mg/kg of IV Atracurium. General anaesthesia will be maintained with mechanical ventilation with isoflurane with O2 \ Air mixture.
During anaesthesia maintenance Intraoperatively, if BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine will be given to stabilize the patients' haemodynamics.
All patients will receive 1g intravenous paracetamol and 4mg ondansetron 8mg dexamethasone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external oblique intercostal block after induction | Active comparator | Procedure: external oblique intercostal blockAfter induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted. Initially the probe is placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line with the xiphoid process. To confirm correct identification of the external oblique muscle, With 17gauge echogenic ultrasound needle will be advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle.30 ml of bupivacaine 0.25% will be administered incrementally. |
| postoperative morphine per patient request | No intervention | –In this group no block will be done only morphine will be given intraoperatively- according to hemodynamic change and postoperative by morphine per patient request |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will be older than 18 years old with American society of anestheologist ASA physical status I, II and III scheduled for Trans-Abdominal ( Anterior Subcostal) Nephrectomy
Key exclusion criteria (8 listed)
- Patients who are:
- Unable to cooperate.
- Patients who have allergy to any of the study drugs.
- Patients who are on opioids.
- Known abuse of alcohol or medication.
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 |
|---|---|---|
| external oblique intercostal block20 ml of bupivacaine 0.25% will be administered by US into external oblique intercostal plane at the level of sixth rib space . | Procedure or surgery | external oblique intercostal block after induction |
Primary outcome
Time for first rescue analgesia
Time frame: day 0
hours
2 secondary outcomes
VAS score
Time frame: 24 hours
rescue analgesics
Time frame: 24hous
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
AMAL G SAFAN, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external oblique intercostal block in people with Postoperative Pain, run by Menoufia 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 1 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: finished, as of the sponsor's last update on 5 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for first rescue analgesia (time frame: day 0). 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 5 Sep 2025.