- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233603
S-TAP vs RSB in Midline Abdominal Incision Laparotomy
November 14, 2025 updated by: Oguz Gundogdu, Cumhuriyet University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sivas
-
Sivas, Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: RSB
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.
|
20 mL of 0.25% bupivacaine on each side
|
|
Active Comparator: S-TAP
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.
|
20 mL of 0.25% bupivacaine on each side
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Postoperative 24 hours
|
|
Total tramadol consumption
Time Frame: Postoperative 24 hours
|
Postoperative total rescue analgesic need was recorded as "milligram" in unit.
|
Postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oğuz Gündoğdu, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
June 1, 2025
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-03/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of ManitobaUnknown
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
Clinical Trials on Rectus Sheath Block
-
Quaid-e-Azam Medical CollegeCompleted
-
Marmara UniversityActive, not recruitingPain Management | Postoperative AnalgesiaTurkey (Türkiye)
-
Cairo UniversityUnknown
-
Diskapi Yildirim Beyazit Education and Research...RecruitingPain Management | Percutaneous Internal Ring SuturingTurkey (Türkiye)
-
Istinye UniversityNot yet recruitingPostoperative PainTurkey (Türkiye)
-
Udayana UniversityRS Prof. Dr. I.G.N.G NgoerahCompletedPostoperative Pain | Abdominal Surgery by LaparotomyIndonesia
-
Chiang Mai UniversityNot yet recruitingAnalgesia | Rectus Sheath Block | Transverse Abdominis Plane Block | Opioid Consumption, PostoperativeThailand
-
Kocaeli UniversityCompletedPostoperative PainTurkey
-
Umraniye Education and Research HospitalActive, not recruitingErector Spinae Plane Block | Laparoscopic Inguinal Hernia RepairTurkey (Türkiye)
-
Sisli Hamidiye Etfal Training and Research HospitalNot yet recruitingPostoperative Pain | Cholecystitis | CholelithiasesTurkey (Türkiye)