Intertransverse Process BlockNCT07591129
Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block After Laparoscopic Sleeve Gastrectomy
A study testing Intertransverse Process Block and The Subcostal Transversus Abdominis Plane Block (TAPB) in people with Intertransverse Process Block and Subcostal Transverse Abdominis Plane Block, run by Antalya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal Transversus Abdominis Plane Block (TAPB) in patients undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intertransverse Process Block, Subcostal Transverse Abdominis Plane Block, Sleeve Gastrectomy
- What is being tested?
- Intertransverse Process Block and The Subcostal Transversus Abdominis Plane Block (TAPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2026to 30 May 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic sleeve gastrectomy
- Body mass index (BMI) >35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Who cannot join
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
Show all 9Show fewer
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) >35 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Antalya Şehir Hastanesi
Antalya
Mustafa KILIN, consultant in anesthesiology, +905464569218, mustafa.kilin90@gmail.com
About this study
Official title: Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Controlled Trial
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal Transversus Abdominis Plane Block (TAPB) in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block-related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Read the detailed description
Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and Subcostal Transversus Abdominis Plane Block (TAPB) on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic sleeve gastrectomy. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) >35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.
Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group TAPB will receive a bilateral subcostal TAP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.
ITP Block :
Intertransverse Process Block (ITP) will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae.
Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.
Subcostal TAP Block:
The Subcostal Transversus Abdominis Plane Block (TAPB) will be performed 30 minutes prior to surgery with the patient in a supine position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned parallel to the lower costal margin.
Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle.. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.
General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey). Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.
Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 4 mg intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU). Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.
Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively.
All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours.
Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.
Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.
Patient Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.
Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:
0 = none
- = mild
- = moderate
- = severe
Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
- Conditions
- Intertransverse Process Block, Subcostal Transverse Abdominis Plane Block, Sleeve Gastrectomy, Postoperative Pain, Regional Anaesthesia
- Being tested
- Intertransverse Process Block, The Subcostal Transversus Abdominis Plane Block (TAPB)
- Keywords
- ITP, TAP, PAİN, SLEEVE GASTRECTOMİ
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intertransverse Process BlockProcedure or surgery
Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae.
Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
The Subcostal Transversus Abdominis Plane Block (TAPB)Procedure or surgery
After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned parallel to the lower costal margin.
Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Intertransverse Process Block (ITPB) | Active comparator | Not described Receives: Procedure: Intertransverse Process Block |
| Subcostal Transversus Abdominis Plane Block (TAPB) | Active comparator | Not described Receives: Procedure: The Subcostal Transversus Abdominis Plane Block (TAPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (VAS score)
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Measured: 0, 1, 4, 8, 12, and 24 hours after surgery
Secondary outcomes (6)
Total opioid consumption via patient-controlled analgesia (PCA)
Measured: Within the first 24 hours postoperatively
Requirement for rescue analgesia
Measured: Within the first 24 hours postoperatively
Potential Complications
Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
Measured: Within the first 24 hours postoperatively
Patient satisfaction
Patient and surgeon satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Measured: At 24 hours postoperatively
Quality of recovery assessed using the QoR-15 questionnaire
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery.
Measured: At 24 hours postoperatively
İncedence of postoperative nausea and vomiting
Measured: Within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertransverse Process 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kılın, Antalya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591129
- Sponsor's protocol ID
- ITP-Subcostal TAP
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07591129
- Acronym / sponsor ID
- ITP-Subcostal TAP
- Conditions
- Intertransverse Process Block, Subcostal Transverse Abdominis Plane Block, Sleeve Gastrectomy, Postoperative Pain, Regional Anaesthesia
- Keywords
- ITP, TAP, PAİN, SLEEVE GASTRECTOMİ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Antalya City HospitalUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 15 May 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 randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal Transversus Abdominis Plane Block (TAPB) in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block-related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Detailed description
Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and Subcostal Transversus Abdominis Plane Block (TAPB) on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic sleeve gastrectomy. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) >35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.
Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group TAPB will receive a bilateral subcostal TAP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.
ITP Block :
Intertransverse Process Block (ITP) will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae.
Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.
Subcostal TAP Block:
The Subcostal Transversus Abdominis Plane Block (TAPB) will be performed 30 minutes prior to surgery with the patient in a supine position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned parallel to the lower costal margin.
Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle.. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound guidance.
General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey). Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO# maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.
Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 4 mg intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU). Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.
Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively.
All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours.
Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.
Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.
Patient Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.
Nausea and Vomiting: Nausea and vomiting will be scored using a 4-point scale:
0 = none
- = mild
- = moderate
- = severe
Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intertransverse Process Block (ITPB) | Active comparator | Procedure: Intertransverse Process Block |
| Subcostal Transversus Abdominis Plane Block (TAPB) | Active comparator | Procedure: The Subcostal Transversus Abdominis Plane Block (TAPB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic sleeve gastrectomy
- Body mass index (BMI) >35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
Key exclusion criteria (9 listed)
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
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 |
|---|---|---|
| Intertransverse Process BlockUltrasound System, Model DC-T6) will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae. Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance. | Procedure or surgery | Intertransverse Process Block (ITPB) |
| The Subcostal Transversus Abdominis Plane Block (TAPB)After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned parallel to the lower costal margin. Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted into the fascial plane between the posterior rectus sheath and the transversus abdominis muscle. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance. | Procedure or surgery | Subcostal Transversus Abdominis Plane Block (TAPB) |
Primary outcome
Postoperative pain intensity (VAS score)
Time frame: 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
6 secondary outcomes
Total opioid consumption via patient-controlled analgesia (PCA)
Time frame: Within the first 24 hours postoperatively
Requirement for rescue analgesia
Time frame: Within the first 24 hours postoperatively
Potential Complications
Time frame: Within the first 24 hours postoperatively
Patient satisfaction
Time frame: At 24 hours postoperatively
Quality of recovery assessed using the QoR-15 questionnaire
Time frame: At 24 hours postoperatively
İncedence of postoperative nausea and vomiting
Time frame: Within the first 24 hours postoperatively
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 15 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intertransverse Process Block and The Subcostal Transversus Abdominis Plane Block (TAPB) in people with Intertransverse Process Block and Subcostal Transverse Abdominis Plane Block, run by Antalya City Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 15 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 Turkey (Türkiye). 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 Mustafa KILIN, consultant in anesthesiology (+905464569218, mustafa.kilin90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (VAS score) (time frame: 0, 1, 4, 8, 12, and 24 hours after surgery). 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 15 May 2026.