Regional BlockNCT07336043
External Oblique Intercostal Block Versus Transversus Abdominis Plane Block in Pediatric Laparoscopic Splenectomy
A study testing EOI group and TAP group in people with Regional Block and Pediatric, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Regional Block, Pediatric, Laparoscopic Splenectomy
- What is being tested?
- EOI group and TAP group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2026to 30 Jul 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both gender,
- aged 8 to 16 years with American Society of Anesthesiologists Physical Status I to III,
- who were scheduled for laparoscopic Splenectomy surgery.
Who cannot join
- Parents declined to participate in the trial.
- Physical or developmental delay.
- Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders.
- Infection at proposed injection sites.
- Prior major abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Regional Analgesia in Pediatric Laparoscopic Splenectomy: External Oblique Intercostal Block Versus Transversus Abdominis Plane Block: Randomized Controlled Study
The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.
Read the detailed description
Optimal postoperative pain control in children is particularly challenging despite advances in multimodal pharmaceutical strategies. Laparoscopic approaches have improved postoperative outcomes when compared to open surgery, particularly in terms of postoperative pain. Pain after laparoscopic surgeries has three components; including incisional, visceral, and referred shoulder pain secondary to peritoneal insufflation. Opioid analgesia can be an effective adjunct to an existing non-opioid pain regimen. However, opioids are known to decrease bowel motility, result in nausea, and cause respiratory depression, particularly in the pediatrics. Traditionally, neuraxial blocks have been used for abdominal surgeries but in patients with low platelet count as splenectomy, this might not be a feasible option.
Effective fascial plane blocks have recently become popular as candidates to be a part of multimodal analgesia, especially for patients who require limited use of drugs in multimodal analgesia (such as liver failure, renal failure, platelet dysfunction, and peptic ulcer) or those with hypersensitivity to any of these drugs. As there are potential advantages such as a longer distance between the needle and neurovascular structures, less motor blockade and less hemodynamic change, fascial plane blocks can provide effective solutions to many difficulties faced by anesthesiologists in the perioperative period. Transversus Abdominis Plane block has emerged as an effective method to minimize postoperative pain in adult patients undergoing abdominal surgery. Several randomized trials in children undergoing laparoscopic appendicectomy, minimally invasive cholecystectomy, and other laparoscopic abdominal procedures have demonstrated that ultrasound-guided Transversus Abdominis Plane block reduces pain scores, opioid consumption, and even pulmonary complications such as atelectasis when compared with port site infiltration or systemic analgesia alone.
External oblique intercostal block is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. External oblique intercostal block block targets the external oblique intercostal plane, allowing for effective analgesia across the upper abdominal wall, including both median and lateral regions. This contrasts with the Transversus Abdominis Plane block block, which may not adequately cover the lateral cutaneous intercostal branches, limiting its effectiveness in certain surgical procedures. Many previous studies that have concentrated on the use of different TAP block strategies, including subcostal Transversus Abdominis Plane block; have shown that it could not sufficiently block the lateral cutaneous intercostal branches.
The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.
- Primary outcome: Postoperative Numerical rating scale score.
- Secondary outcomes
- The amount of morphine consumption postoperatively.
- Time to first opioid request .
- Intraoperative fentanyl consumption.
- Intraoperative vital signs including mean arterial pressure and heart rate.
- Conditions
- Regional Block, Pediatric, Laparoscopic Splenectomy, External Oblique Intercostal Block, Transversus Abdominis Plane Block
- Being tested
- EOI group, TAP group
- Keywords
- Pediatric, External Oblique Intercostal Block, Transversus Abdominis Plane Block, Regional Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOI groupProcedure or surgery
patients will receive ultrasound-guided left EOI block.
TAP groupProcedure or surgery
patients will receive ultrasound-guided left TAP block
| Study group | Role | What they receive |
|---|---|---|
| EOI group (Group E) | Experimental | 30 patients will receive ultrasound-guided left EOI block Receives: Procedure: EOI group |
| TAP group (Group T) | Experimental | 30 patients will receive ultrasound-guided left TAP block Receives: Procedure: TAP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale score
Numerical rating scale score
Measured: Numerical rating scale score will be assessed postoperatively 10, 30 and 60 minutes then 2 , 4 , 6 , 12 , 24 hours postoperatively
Secondary outcomes (1)
Intraoperative Heart rate values
Intraoperative Heart rate values at the time of port placement and every 15 min until end of surgery
Measured: every 15 minutes until 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 posted13 Jan 2026
- Study start13 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Rabie Amer, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336043
- Sponsor's protocol ID
- 36264PR131092/11/25
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be provided if it was needed
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Regional Analgesia in Pediatric Laparoscopic Splenectomy: External Oblique Intercostal Block Versus Transversus Abdominis Plane Block: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07336043
- Acronym / sponsor ID
- 36264PR131092/11/25
- Conditions
- Regional Block, Pediatric, Laparoscopic Splenectomy, External Oblique Intercostal Block, Transversus Abdominis Plane Block
- Keywords
- Pediatric, External Oblique Intercostal Block, Transversus Abdominis Plane Block, Regional Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 13 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.
The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.
Detailed description
Optimal postoperative pain control in children is particularly challenging despite advances in multimodal pharmaceutical strategies. Laparoscopic approaches have improved postoperative outcomes when compared to open surgery, particularly in terms of postoperative pain. Pain after laparoscopic surgeries has three components; including incisional, visceral, and referred shoulder pain secondary to peritoneal insufflation. Opioid analgesia can be an effective adjunct to an existing non-opioid pain regimen. However, opioids are known to decrease bowel motility, result in nausea, and cause respiratory depression, particularly in the pediatrics. Traditionally, neuraxial blocks have been used for abdominal surgeries but in patients with low platelet count as splenectomy, this might not be a feasible option.
Effective fascial plane blocks have recently become popular as candidates to be a part of multimodal analgesia, especially for patients who require limited use of drugs in multimodal analgesia (such as liver failure, renal failure, platelet dysfunction, and peptic ulcer) or those with hypersensitivity to any of these drugs. As there are potential advantages such as a longer distance between the needle and neurovascular structures, less motor blockade and less hemodynamic change, fascial plane blocks can provide effective solutions to many difficulties faced by anesthesiologists in the perioperative period. Transversus Abdominis Plane block has emerged as an effective method to minimize postoperative pain in adult patients undergoing abdominal surgery. Several randomized trials in children undergoing laparoscopic appendicectomy, minimally invasive cholecystectomy, and other laparoscopic abdominal procedures have demonstrated that ultrasound-guided Transversus Abdominis Plane block reduces pain scores, opioid consumption, and even pulmonary complications such as atelectasis when compared with port site infiltration or systemic analgesia alone.
External oblique intercostal block is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. External oblique intercostal block block targets the external oblique intercostal plane, allowing for effective analgesia across the upper abdominal wall, including both median and lateral regions. This contrasts with the Transversus Abdominis Plane block block, which may not adequately cover the lateral cutaneous intercostal branches, limiting its effectiveness in certain surgical procedures. Many previous studies that have concentrated on the use of different TAP block strategies, including subcostal Transversus Abdominis Plane block; have shown that it could not sufficiently block the lateral cutaneous intercostal branches.
The aim of study is to compare the efficacy of the External Oblique Intercostal plane block with the Transversus Abdominis Plane block in acute postoperative pain control in pediatric patients undergoing laparoscopic Splenectomy.
- Primary outcome: Postoperative Numerical rating scale score.
- Secondary outcomes
- The amount of morphine consumption postoperatively.
- Time to first opioid request .
- Intraoperative fentanyl consumption.
- Intraoperative vital signs including mean arterial pressure and heart rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOI group (Group E) | Experimental | Procedure: EOI group30 patients will receive ultrasound-guided left EOI block |
| TAP group (Group T) | Experimental | Procedure: TAP group30 patients will receive ultrasound-guided left TAP block |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of both gender,
- aged 8 to 16 years with American Society of Anesthesiologists Physical Status I to III,
- who were scheduled for laparoscopic Splenectomy surgery.
Key exclusion criteria (5 listed)
- Parents declined to participate in the trial.
- Physical or developmental delay.
- Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders.
- Infection at proposed injection sites.
- Prior major abdominal surgery
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 |
|---|---|---|
| EOI grouppatients will receive ultrasound-guided left EOI block. | Procedure or surgery | EOI group (Group E) |
| TAP grouppatients will receive ultrasound-guided left TAP block | Procedure or surgery | TAP group (Group T) |
Primary outcome
Numerical rating scale score
Time frame: Numerical rating scale score will be assessed postoperatively 10, 30 and 60 minutes then 2 , 4 , 6 , 12 , 24 hours postoperatively
Numerical rating scale score
1 secondary outcome
Intraoperative Heart rate values
Time frame: every 15 minutes until end of surgery
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 22 May 2026.
- Individual participant dataSharing planned: Yes. All data will be provided if it was needed
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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 EOI group and TAP group in people with Regional Block and Pediatric, 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 May 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?
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?
Numerical rating scale score (time frame: Numerical rating scale score will be assessed postoperatively 10, 30 and 60 minutes then 2 , 4 , 6 , 12 , 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 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.