Postoperative PainNCT07233603
S-TAP vs RSB in Midline Abdominal Incision Laparotomy
A study testing Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block in people with Postoperative Pain and Laparotomy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to compare the postoperative analgesic effects of Subcostal Transversus Abdominis Plane Block (S-TAP) versus Rectus Sheath Block (RSB) in patients undergoing laparotomy with midline abdominal incision. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Laparotomy
- What is being tested?
- Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block
- Type of treatment
- 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
- 1 Jun 2023to 1 Feb 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients older than 18 years of age who underwent laparotomy with midline incision under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Who cannot join
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
- patients who received ileostomy or colostomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas, 58140
About this study
Official title: Comparison of the Effects of Subcostal Transversus Abdominis Plane Block Versus Rectus Sheath Block on Postoperative Pain in Midline Abdominal Incision Laparotomy
The aim is to compare the postoperative analgesic effects of Subcostal Transversus Abdominis Plane Block (S-TAP) versus Rectus Sheath Block (RSB) in patients undergoing laparotomy with midline abdominal incision.
Read the detailed description
Patients were divided into two randomized groups: Group 1 (S-TAP group, n=30) and Group 2 (RSB group, n=30). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After the surgery was completed, patients in Group 1 will receive subcostal transversus abdominis plane block (S-TAP) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Patients in Group 2 will receive rectus sheath block (RSB) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.
- Conditions
- Postoperative Pain, Laparotomy
- Being tested
- Subcostal Transversus Abdominis Plane Block, Rectus Sheath Block
- Keywords
- postoperative pain, regional anesthesia, laparotomy, midline incision, subcostal transversus abdominis plane block, rectus sheath block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Transversus Abdominis Plane BlockProcedure or surgery
20 mL of 0.25% bupivacaine on each side
Rectus Sheath BlockProcedure or surgery
20 mL of 0.25% bupivacaine on each side
| Study group | Role | What they receive |
|---|---|---|
| S-TAP | Active comparator | For this group, S-TAP blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For S-TAP, a high frequency linear transducer USG is placed below the xiphoid process, on the linea alba transversely. The probe will then be moved laterally along the costal margin with a slight oblique motion to match the costal arc until the transversus abdominis muscle is visualized under the rectus abdominis muscle. The block needle will be inserted in-plane from inferolateral to superomedial direction, aiming toward the fascial plane between transversus abdominis and rectus abdominis muscles. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally. Receives: Procedure: Subcostal Transversus Abdominis Plane Block |
| RSB | Active comparator | For this group, RS blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For RSB, a high frequency linear transducer USG is placed above the umbilicus transversely. The probe will then be moved laterally until the rectus abdominis muscle, its posterior sheath and the peritoneum can be visualized clearly. The block needle will be inserted in-plane from lateral to medial direction, aiming toward the posterior sheath of the rectus abdominis muscle. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally. Receives: Procedure: Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Scores
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Total tramadol consumption
Postoperative total rescue analgesic need was recorded as "milligram" in unit.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jun 2023
- Primary completion1 Jun 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233603
- Sponsor's protocol ID
- 2023-03/01
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Subcostal Transversus Abdominis Plane Block Versus Rectus Sheath Block on Postoperative Pain in Midline Abdominal Incision Laparotomy
- ClinicalTrials.gov ID
- NCT07233603
- Acronym / sponsor ID
- 2023-03/01
- Conditions
- Postoperative Pain, Laparotomy
- Keywords
- postoperative pain, regional anesthesia, laparotomy, midline incision, subcostal transversus abdominis plane block, rectus sheath block
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Nov 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.
The aim is to compare the postoperative analgesic effects of Subcostal Transversus Abdominis Plane Block (S-TAP) versus Rectus Sheath Block (RSB) in patients undergoing laparotomy with midline abdominal incision.
Detailed description
Patients were divided into two randomized groups: Group 1 (S-TAP group, n=30) and Group 2 (RSB group, n=30). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After the surgery was completed, patients in Group 1 will receive subcostal transversus abdominis plane block (S-TAP) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Patients in Group 2 will receive rectus sheath block (RSB) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-TAP | Active comparator | Procedure: Subcostal Transversus Abdominis Plane BlockFor this group, S-TAP blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For S-TAP, a high frequency linear transducer USG is placed below the xiphoid process, on the linea alba transversely. The probe will then be moved laterally along the costal margin with a slight oblique motion to match the costal arc until the transversus abdominis muscle is visualized under the rectus abdominis muscle. The block needle will be inserted in-plane from inferolateral to superomedial direction, aiming toward the fascial plane between transversus abdominis and rectus abdominis muscles. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally. |
| RSB | Active comparator | Procedure: Rectus Sheath BlockFor this group, RS blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For RSB, a high frequency linear transducer USG is placed above the umbilicus transversely. The probe will then be moved laterally until the rectus abdominis muscle, its posterior sheath and the peritoneum can be visualized clearly. The block needle will be inserted in-plane from lateral to medial direction, aiming toward the posterior sheath of the rectus abdominis muscle. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients older than 18 years of age who underwent laparotomy with midline incision under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Key exclusion criteria (8 listed)
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
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 |
|---|---|---|
| Subcostal Transversus Abdominis Plane Block20 mL of 0.25% bupivacaine on each side | Procedure or surgery | S-TAP |
| Rectus Sheath Block20 mL of 0.25% bupivacaine on each side | Procedure or surgery | RSB |
Primary outcome
Numeric Rating Scale (NRS) Scores
Time frame: Postoperative 24 hours
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Total tramadol consumption
Time frame: Postoperative 24 hours
Postoperative total rescue analgesic need was recorded as "milligram" in unit.
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 18 Nov 2025.
- 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. This study is not recruiting at the moment.
Oğuz Gündoğdu principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal Transversus Abdominis Plane Block and Rectus Sheath Block in people with Postoperative Pain and Laparotomy, run by Cumhuriyet University 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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 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 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?
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?
Numeric Rating Scale (NRS) Scores (time frame: Postoperative 24 hours). The study lists 2 primary outcomes in all. 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 18 Nov 2025.