Subtransverse Interligamentary BlockNCT07138794
Ultrasound-Guided Subtransverse Interligamentary Block Versus Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy
A study testing Subtransverse process interligamentary and Thoracic paravertebral block in people with Subtransverse Interligamentary Block and Thoracic Paravertebral Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare ultrasound-guided subtransverse process interligamentary (STIL) block versus thoracic paravertebral block (TPVB) for postoperative analgesia in patients undergoing open nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subtransverse Interligamentary Block, Thoracic Paravertebral Block, Postoperative Analgesia
- What is being tested?
- Subtransverse process interligamentary and Thoracic paravertebral block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2025to 1 Apr 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing open nephrectomy under general anesthesia.
Who cannot join
- History of allergies to local anesthetics.
- Opioid dependency.
- Bleeding or coagulation disorders.
- Psychiatric and neurological disorder.
- Local infection at the site of injection.
- Body mass index (BMI) > 35 kg/m2.
- Severe heart, lung, liver, and renal dysfunction.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Subtransverse Interligamentary Block Versus Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Randomized Clinical Trial
This study aims to compare ultrasound-guided subtransverse process interligamentary (STIL) block versus thoracic paravertebral block (TPVB) for postoperative analgesia in patients undergoing open nephrectomy.
Read the detailed description
Acute pain physiopathology is explained as it is mediated by inflammatory cell infiltration, activation of spinal cord pain pathways, and also by reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery.
A thoracic paravertebral block (TPVB) shows comparable analgesic efficacy with fewer side effects compared with thoracic epidural analgesia in patients undergoing thoracotomy.
The recently introduced subtransverse process interligamentary (STIL) block offers a safer alternative by targeting thoracic nerves without entering paravertebral space.
- Conditions
- Subtransverse Interligamentary Block, Thoracic Paravertebral Block, Postoperative Analgesia, Open Nephrectomy
- Being tested
- Subtransverse process interligamentary, Thoracic paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtransverse process interligamentaryOther
Patients will receive subtransverse process interligamentary (STIL) block using 20ml of bupivacaine 0.25%.
Thoracic paravertebral blockOther
Patients will receive a thoracic paravertebral block (TPVB) using 20ml of bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| STIL group | Experimental | Patients will receive subtransverse process interligamentary (STIL) block using 20ml of bupivacaine 0.25%. Receives: Other: Subtransverse process interligamentary |
| TPVB group | Experimental | Patients will receive a thoracic paravertebral block (TPVB) using 20ml of bupivacaine 0.25%. Receives: Other: Thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
Measured: 48 hours postoperatively
Secondary outcomes (6)
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated.
Measured: 48 hours postoperatively
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 0.5 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
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Heart rate
Heart rate will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at PACU, 2, 4, 6, 8, 12, 18, 24, 36, and 48 h postoperatively.
Measured: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, pruritus, or any other complication will be recorded.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start23 Aug 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtransverse Interligamentary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 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
- NCT07138794
- Sponsor's protocol ID
- 36264PR1283/7/25
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2025
- Last updated
- 22 Apr 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Subtransverse Interligamentary Block Versus Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07138794
- Acronym / sponsor ID
- 36264PR1283/7/25
- Conditions
- Subtransverse Interligamentary Block, Thoracic Paravertebral Block, Postoperative Analgesia, Open Nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 24 Aug 2025 (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 (STIL) block versus thoracic paravertebral block (TPVB) for postoperative analgesia in patients undergoing open nephrectomy.
Detailed description
Acute pain physiopathology is explained as it is mediated by inflammatory cell infiltration, activation of spinal cord pain pathways, and also by reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery.
A thoracic paravertebral block (TPVB) shows comparable analgesic efficacy with fewer side effects compared with thoracic epidural analgesia in patients undergoing thoracotomy.
The recently introduced subtransverse process interligamentary (STIL) block offers a safer alternative by targeting thoracic nerves without entering paravertebral space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STIL group | Experimental | Other: Subtransverse process interligamentaryPatients will receive subtransverse process interligamentary (STIL) block using 20ml of bupivacaine 0.25%. |
| TPVB group | Experimental | Other: Thoracic paravertebral blockPatients will receive a thoracic paravertebral block (TPVB) using 20ml of bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing open nephrectomy under general anesthesia.
Key exclusion criteria (8 listed)
- History of allergies to local anesthetics.
- Opioid dependency.
- Bleeding or coagulation disorders.
- Psychiatric and neurological disorder.
- Local infection at the site of injection.
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 |
|---|---|---|
| Subtransverse process interligamentaryPatients will receive subtransverse process interligamentary (STIL) block using 20ml of bupivacaine 0.25%. | Other | STIL group |
| Thoracic paravertebral blockPatients will receive a thoracic paravertebral block (TPVB) using 20ml of bupivacaine 0.25%. | Other | TPVB group |
Primary outcome
Total morphine consumption
Time frame: 48 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
6 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 48 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Mean arterial pressure
Time frame: Till the end of surgery (Up to 2 hours)
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Degree of pain
Time frame: 48 hours postoperatively
Incidence of adverse events
Time frame: 48 hours postoperatively
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 22 Apr 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. 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 Subtransverse process interligamentary and Thoracic paravertebral block in people with Subtransverse Interligamentary Block and Thoracic Paravertebral 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 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 22 Apr 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?
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?
Total morphine consumption (time frame: 48 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 Apr 2026.