Subtransverse Process Interligamentary Plane BlockNCT07666334
Subtransverse Process Interligamentary Plane Block Versus Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block for Analgesia in Pediatric Thoracotomy
A study testing Standard intravenous analgesia, Subtransverse process interligamentary plane block and Rhomboid intercostal block (RIB) combined with sub-serratus plan block group in people with Subtransverse Process Interligamentary Plane Block and Rhomboid Intercostal Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare ultrasound guided subtransverse process interligamentary plane block versus rhomboid intercostal block combined with sub-serratus plane block for postoperative analgesia in pediatric thoracotomy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Subtransverse Process Interligamentary Plane Block, Rhomboid Intercostal Block, Sub-Serratus Plane Block
- What is being tested?
- Standard intravenous analgesia, Subtransverse process interligamentary plane block and Rhomboid intercostal block (RIB) combined with sub-serratus plan block group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Sep 2027
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients between 6 to 12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I - II.
- Scheduled for thoracic surgery with thoracotomy incision under general anesthesia.
Who cannot join
- Parents who refused regional anesthesia.
- Patients were presented with advanced kidney, cardiac or liver diseases.
- Coagulation and bleeding disorders.
- Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- Patients with cognitive impairment.
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, El-Gharbia, 31527
Walaa A Elbialy, MSc, 00201095519412, walaaelbialy156@gmail.com
Lobna M AboAlnassr, MD
About this study
Official title: Ultrasound- Guided Subtransverse Process Interligamentary Plane Block Versus Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study
This study aims to compare ultrasound guided subtransverse process interligamentary plane block versus rhomboid intercostal block combined with sub-serratus plane block for postoperative analgesia in pediatric thoracotomy.
Read the detailed description
Post-thoracotomy pain is one of the most severe types of pain on the first day of the surgery. In pediatric patients, inadequate analgesia may lead to adverse circulatory and respiratory compromise.
The subtransverse process interligamentary (STIL) plane block is a recently introduced technique that offers a safer alternative by targeting thoracic nerves without entering the paravertebral space.
Recently, some studies have shown that the rhomboid intercostal block (RIB) and the RIB combined with the sub-serratus plane block (RISS) can provide good analgesia effects after video assisted thoracoscope.
- Conditions
- Subtransverse Process Interligamentary Plane Block, Rhomboid Intercostal Block, Sub-Serratus Plane Block, Analgesia, Pediatric Thoracotomy
- Being tested
- Standard intravenous analgesia, Subtransverse process interligamentary plane block, Rhomboid intercostal block (RIB) combined with sub-serratus plan block group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard intravenous analgesiaOther
Patients will receive no block intervention and standard intravenous analgesia will be given.
Subtransverse process interligamentary plane blockOther
Patients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia.
Rhomboid intercostal block (RIB) combined with sub-serratus plan block groupOther
Patients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will receive no block intervention and standard intravenous analgesia will be given. Receives: Other: Standard intravenous analgesia |
| STIL block | Experimental | Patients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia. Receives: Other: Subtransverse process interligamentary plane block |
| RISS block group | Experimental | Patients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia. Receives: Other: Rhomboid intercostal block (RIB) combined with sub-serratus plan block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Time to the first rescue analgesia will be recorded from the end of surgery till first dose of morphine adminstrated.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Degree of pain
Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed after surgery over 24 hours (30 minutes postoperative, 2, 4, 6, 12, 24 hours.
Measured: 24 hours postoperatively
Total Opioids consumption
Morphine 0.05 mg /kg IV will be given as rescue analgesia if VAS score ≥4, morphine dose will not exceed 0.3 mg/kg/day.
Measured: 24 hours postoperatively
Intraoperative fentanyl consumption
Fentanyl 0.5 μg/kg will be administrated in the case of inadequate analgesia that defined as an un explained increase of heart rate (HR) and/or mean arterial blood pressure (MAP) more than 20% above the preoperative values after exclusion of other causes.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtransverse Process Interligamentary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Adel Elbialy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666334
- Sponsor's protocol ID
- 36265MD454/8/25
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound- Guided Subtransverse Process Interligamentary Plane Block Versus Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07666334
- Acronym / sponsor ID
- 36265MD454/8/25
- Conditions
- Subtransverse Process Interligamentary Plane Block, Rhomboid Intercostal Block, Sub-Serratus Plane Block, Analgesia, Pediatric Thoracotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Jun 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 compare ultrasound guided subtransverse process interligamentary plane block versus rhomboid intercostal block combined with sub-serratus plane block for postoperative analgesia in pediatric thoracotomy.
Detailed description
Post-thoracotomy pain is one of the most severe types of pain on the first day of the surgery. In pediatric patients, inadequate analgesia may lead to adverse circulatory and respiratory compromise.
The subtransverse process interligamentary (STIL) plane block is a recently introduced technique that offers a safer alternative by targeting thoracic nerves without entering the paravertebral space.
Recently, some studies have shown that the rhomboid intercostal block (RIB) and the RIB combined with the sub-serratus plane block (RISS) can provide good analgesia effects after video assisted thoracoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard intravenous analgesiaPatients will receive no block intervention and standard intravenous analgesia will be given. |
| STIL block | Experimental | Other: Subtransverse process interligamentary plane blockPatients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia. |
| RISS block group | Experimental | Other: Rhomboid intercostal block (RIB) combined with sub-serratus plan block groupPatients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients between 6 to 12 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status I - II.
- Scheduled for thoracic surgery with thoracotomy incision under general anesthesia.
Key exclusion criteria (5 listed)
- Parents who refused regional anesthesia.
- Patients were presented with advanced kidney, cardiac or liver diseases.
- Coagulation and bleeding disorders.
- Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- Patients with cognitive impairment.
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 |
|---|---|---|
| Standard intravenous analgesiaPatients will receive no block intervention and standard intravenous analgesia will be given. | Other | Control Group |
| Subtransverse process interligamentary plane blockPatients will receive ipsilateral ultrasound-guided subtransverse process interligamentary (STIL) plane block with bupivacaine 0.25% (0.5 mL/kg) after induction of general anesthesia. | Other | STIL block |
| Rhomboid intercostal block (RIB) combined with sub-serratus plan block groupPatients will receive ipsilateral ultrasound-guided rhomboid intercostal block (RIB) combined with sub-serratus plan block group with bupivacaine 0.25% (0.5mL/kg) after induction of general anesthesia. | Other | RISS block group |
Primary outcome
Time to first rescue analgesia
Time frame: 24 hours postoperatively
Time to the first rescue analgesia will be recorded from the end of surgery till first dose of morphine adminstrated.
3 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Total Opioids consumption
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
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 24 Jun 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.
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 Standard intravenous analgesia, Subtransverse process interligamentary plane block and Rhomboid intercostal block (RIB) combined with sub-serratus plan block group in people with Subtransverse Process Interligamentary Plane Block and Rhomboid Intercostal 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 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: looking for participants now, as of the sponsor's last update on 24 Jun 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 Walaa A Elbialy, MSc (00201095519412, walaaelbialy156@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first 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 24 Jun 2026.