Transversus Abdominis Plane BlockNCT06452225
Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
A study testing External Oblique Intercostal Plane Block and Transversus Abdominis Plane Block in people with Transversus Abdominis Plane Block and External Oblique Intercostal Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Transversus Abdominis Plane Block, External Oblique Intercostal Plane Block, Postoperative Analgesia
- What is being tested?
- External Oblique Intercostal Plane Block and Transversus Abdominis Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2024to 20 Oct 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≤ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Scheduled for open nephrectomy.
Who cannot join
- Abnormal blood coagulation.
- Scar, infection, and tumor of puncture site.
- History or family history of high malignant fever.
- Severe cardiovascular problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.
Read the detailed description
Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.
External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .
- Conditions
- Transversus Abdominis Plane Block, External Oblique Intercostal Plane Block, Postoperative Analgesia, Pediatrics, Open Nephrectomy
- Being tested
- External Oblique Intercostal Plane Block, Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique Intercostal Plane BlockOther
Patients will receive external oblique intercostal plane block.
Transversus Abdominis Plane BlockOther
Patients will receive ultrasound guided transversus abdominis plane block.
| Study group | Role | What they receive |
|---|---|---|
| External Oblique Intercostal Plane Block | Experimental | Patients will receive external oblique intercostal plane block. Receives: Other: External Oblique Intercostal Plane Block |
| Transversus Abdominis Plane Block | Experimental | Patients will receive ultrasound guided transversus abdominis plane block. Receives: Other: Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 15 mg /kg/8 hrs as routine analgesia. Rescue analgesia of morphine will be given as 0.05 mg/kg if face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours. FLACC will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively.
it will be measured from the end of surgery to first dose of morphine administrated.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Total morphine consumption
Rescue analgesia of morphine will be given as 0.05 mg/kg if the face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours.
Measured: 24 hours postoperatively
Degree of pain
The pain will be assessed by using the face, legs, activity, and cry consolability scale (FLACC). The level of response for each observation is given a numerical value rating from "0" to "2," with "0" being the most comfortable with no pain and "2" being the most painful , which results in a total score between "0" and "10".
It will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Measured: Every 15 minutes till the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start12 Jun 2024
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Abdominis Plane BlockStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452225
- Sponsor's protocol ID
- 36264PR641/4/24
- Status last verified
- Nov 2025
- First submitted
- 30 May 2024
- Last updated
- 25 Nov 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy
- ClinicalTrials.gov ID
- NCT06452225
- Acronym / sponsor ID
- 36264PR641/4/24
- Conditions
- Transversus Abdominis Plane Block, External Oblique Intercostal Plane Block, Postoperative Analgesia, Pediatrics, Open Nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 11 Jun 2024 (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 aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.
Detailed description
Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.
External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Oblique Intercostal Plane Block | Experimental | Other: External Oblique Intercostal Plane BlockPatients will receive external oblique intercostal plane block. |
| Transversus Abdominis Plane Block | Experimental | Other: Transversus Abdominis Plane BlockPatients will receive ultrasound guided transversus abdominis plane block. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ≤ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Scheduled for open nephrectomy.
Key exclusion criteria (4 listed)
- Abnormal blood coagulation.
- Scar, infection, and tumor of puncture site.
- History or family history of high malignant fever.
- Severe cardiovascular problems.
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 Plane BlockPatients will receive external oblique intercostal plane block. | Other | External Oblique Intercostal Plane Block |
| Transversus Abdominis Plane BlockPatients will receive ultrasound guided transversus abdominis plane block. | Other | Transversus Abdominis Plane Block |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 15 mg /kg/8 hrs as routine analgesia. Rescue analgesia of morphine will be given as 0.05 mg/kg if face, legs, activity, and cry consolability scale (FLACC) ≥ 4 and the maximum allowed dose is 0.1mg/kg every 4 hours. FLACC will be assessed at 0, 2, 4, 8, 12 and 24h postoperatively. it will be measured from the end of surgery to first dose of morphine administrated.
4 secondary outcomes
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Mean arterial pressure
Time frame: Every 15 minutes till the end of surgery
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 25 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Plane Block and Transversus Abdominis Plane Block in people with Transversus Abdominis Plane Block and External Oblique Intercostal Plane Block, 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 4 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 25 Nov 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 to the 1st rescue analgesia (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 25 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.