ObesityTAPNCT07168538
Effect of TAP Block on GI Function After Sleeve Gastrectomy Using PRO-diGI Scale and Perlas Score
An observational study of Obesity and Postoperative Gastrointestinal Dysfunction, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to evaluate the effect of Transversus Abdominis Plane (TAP) block on postoperative gastrointestinal function 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
- Obesity, Postoperative Gastrointestinal Dysfunction
- What is being tested?
- TAP Block Group
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Nov 2025
- Phase
- Observational
- 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
Study population: Adult patients undergoing elective laparoscopic sleeve gastrectomy at Elazığ Fethi Sekin City Hospital. Both male and female patients who meet inclusion criteria and consent to participate will be enrolled consecutively.
Who may be able to join
- Adult patients aged 18-65 years
- Scheduled for primary laparoscopic sleeve gastrectomy (LSG)
- Body Mass Index (BMI) ≥ 35 kg/m²
- ASA Physical Status II-III
- Ability to provide written informed consent
Who cannot join
- Previous major abdominal surgery
- Known allergy to local anesthetics
- Severe hepatic or renal dysfunction
- Pregnancy or breastfeeding
- Conversion to open surgery during the procedure
- Patients refusing TAP block or general anesthesia
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
Elazığ Fethi Sekin City Hospital
Elâzığ, 23100
Serpil Bayındır, MD, 05055493582, serpilbayindir@gmail.com.tr
About this study
Official title: Effect of Transversus Abdominis Plane (TAP) Block on Postoperative Gastrointestinal Function After Laparoscopic Sleeve Gastrectomy: Evaluation Using the PRO-diGI Scale and Perlas Score (Prospective Clinical Study)
This prospective clinical study aims to evaluate the effect of Transversus Abdominis Plane (TAP) block on postoperative gastrointestinal function in patients undergoing laparoscopic sleeve gastrectomy. Gastrointestinal recovery plays a crucial role in patient outcomes after bariatric surgery, and regional anesthesia techniques such as TAP block have been suggested to reduce postoperative pain and opioid consumption, which may influence gut motility.
In this study, postoperative gastrointestinal function will be assessed using the validated Patient-Reported Outcome for Dysfunctional Gastrointestinal Motility (PRO-diGI) scale. Additionally, gastric ultrasound will be performed to calculate the Perlas score as an objective marker of gastric emptying and residual volume. These assessments will allow a comprehensive evaluation of both subjective and objective gastrointestinal recovery parameters.
Read more
The study will include adult patients scheduled for elective laparoscopic sleeve gastrectomy at Elazığ Fethi Sekin City Hospital. Participants will receive standard general anesthesia with or without ultrasound-guided TAP block, and their postoperative recovery will be monitored. Primary outcomes include PRO-diGI scores at defined postoperative intervals, while secondary outcomes include Perlas scores obtained via gastric ultrasonography.
The findings from this research are expected to provide valuable insights into the potential benefits of TAP block on gastrointestinal motility and overall recovery after bariatric surgery.
Read the detailed description
Bariatric surgery, particularly laparoscopic sleeve gastrectomy, is an effective intervention for morbid obesity. However, postoperative gastrointestinal dysfunction, including delayed gastric emptying and impaired gut motility, can adversely impact recovery, prolong hospital stay, and reduce patient satisfaction. Factors such as opioid-based analgesia are known contributors to postoperative ileus and gastrointestinal dysmotility. Therefore, optimizing pain management strategies while minimizing opioid use is critical for enhanced recovery.
The Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that provides effective abdominal wall analgesia, reducing opioid consumption and associated adverse effects. While its role in postoperative pain control is well established, limited evidence exists regarding its impact on gastrointestinal function, particularly in the context of bariatric surgery.
Study Objective:
The primary objective of this study is to evaluate whether the application of ultrasound-guided TAP block affects postoperative gastrointestinal function after laparoscopic sleeve gastrectomy. Gastrointestinal recovery will be assessed using the PRO-diGI scale, which captures patient-reported symptoms of gastrointestinal motility, and the Perlas gastric ultrasound score, which provides an objective estimate of gastric content and residual volume.
Study Design:
This is a prospective, single-center clinical study conducted at Elazığ Fethi Sekin City Hospital. Adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. All participants will receive standardized general anesthesia. TAP block will be administered as part of the perioperative analgesia strategy in eligible patients, based on clinical decision-making and patient consent.
Assessments:
Primary Outcome:
PRO-diGI score measured at predefined postoperative intervals (e.g., 6, 24, and 48 hours after surgery).
Secondary Outcomes:
Perlas score obtained via gastric ultrasonography in the early postoperative period.
Postoperative opioid consumption within the first 48 hours.
Incidence of postoperative nausea, vomiting, and ileus.
Length of hospital stay.
Ethics and Compliance:
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Ethical approval has been obtained from the institutional review board. Written informed consent will be obtained from all participants prior to study inclusion.
Expected Impact:
By integrating both subjective and objective measures of gastrointestinal function, this study will provide high-quality evidence regarding the potential benefits of TAP block beyond pain control. The results may contribute to optimizing perioperative care strategies for bariatric surgery and improving patient outcomes.
- Being tested
- TAP Block Group, Control Group
- Keywords
- TAP Block, Gastrointestinal Motility, PRO-diGI Scale, Sleeve Gastrectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block GroupProcedure or surgery
Bilateral ultrasound-guided transversus abdominis plane block performed at the end of surgery using 20 mL of 0.25% bupivacaine per side.
Control GroupProcedure or surgery
Standard ERAS-based multimodal analgesia protocol without regional block.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Group | Patients receiving bilateral ultrasound-guided TAP block at the end of laparoscopic sleeve gastrectomy as part of multimodal analgesia. Receives: Procedure: TAP Block Group | |
| Control Group | Patients receiving standard multimodal analgesia without TAP block. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Gastrointestinal Function
Description: Assessed using the validated Patient-Reported Outcome for Dysfunction in Gastrointestinal Recovery after Surgery (PRO-diGI) scale, which captures patient-reported symptoms of gastrointestinal motility, including nausea, vomiting, bloating, and oral intake tolerance. The scale ranges from 0 to 15, with higher scores indicating greater gastrointestinal dysfunction and worse postoperative GI function.
Measured: Postoperative 6, 12, 24, and 48 hours
Secondary outcomes (4)
Perlas Score
Description: Gastric content and residual volume were assessed using bedside gastric ultrasound and graded according to the Perlas scoring system to estimate aspiration risk. Score 0 = empty antrum; Score 1 = minimal fluid in the right lateral decubitus; Score 2 = significant fluid in both supine and right lateral decubitus positions.
Measured: Preoperative and immediate postoperative period
Opioid Consumption
Total opioid use in morphine milligram equivalents.
Measured: First 48 hours postoperatively
Pain Scores (NRS)
Patient-reported pain intensity measured using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst possible pain) at rest and during movement. Higher scores indicate greater pain.
Measured: 2, 6, 12, 24, and 48 hours postoperatively
Adverse Events
Incidence of postoperative nausea, vomiting, ileus, or TAP block-related complications.
Measured: From immediately after surgery up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168538
- Sponsor's protocol ID
- FSCH-SBÜ-2025/092
- Acronym
- TAP
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transversus Abdominis Plane (TAP) Block on Postoperative Gastrointestinal Function After Laparoscopic Sleeve Gastrectomy: Evaluation Using the PRO-diGI Scale and Perlas Score (Prospective Clinical Study)
- ClinicalTrials.gov ID
- NCT07168538
- Acronym / sponsor ID
- TAP / FSCH-SBÜ-2025/092
- Keywords
- TAP Block, Gastrointestinal Motility, PRO-diGI Scale, Sleeve Gastrectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Sep 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 prospective clinical study aims to evaluate the effect of Transversus Abdominis Plane (TAP) block on postoperative gastrointestinal function in patients undergoing laparoscopic sleeve gastrectomy. Gastrointestinal recovery plays a crucial role in patient outcomes after bariatric surgery, and regional anesthesia techniques such as TAP block have been suggested to reduce postoperative pain and opioid consumption, which may influence gut motility.
In this study, postoperative gastrointestinal function will be assessed using the validated Patient-Reported Outcome for Dysfunctional Gastrointestinal Motility (PRO-diGI) scale. Additionally, gastric ultrasound will be performed to calculate the Perlas score as an objective marker of gastric emptying and residual volume. These assessments will allow a comprehensive evaluation of both subjective and objective gastrointestinal recovery parameters.
The study will include adult patients scheduled for elective laparoscopic sleeve gastrectomy at Elazığ Fethi Sekin City Hospital. Participants will receive standard general anesthesia with or without ultrasound-guided TAP block, and their postoperative recovery will be monitored. Primary outcomes include PRO-diGI scores at defined postoperative intervals, while secondary outcomes include Perlas scores obtained via gastric ultrasonography.
The findings from this research are expected to provide valuable insights into the potential benefits of TAP block on gastrointestinal motility and overall recovery after bariatric surgery.
Detailed description
Bariatric surgery, particularly laparoscopic sleeve gastrectomy, is an effective intervention for morbid obesity. However, postoperative gastrointestinal dysfunction, including delayed gastric emptying and impaired gut motility, can adversely impact recovery, prolong hospital stay, and reduce patient satisfaction. Factors such as opioid-based analgesia are known contributors to postoperative ileus and gastrointestinal dysmotility. Therefore, optimizing pain management strategies while minimizing opioid use is critical for enhanced recovery.
The Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that provides effective abdominal wall analgesia, reducing opioid consumption and associated adverse effects. While its role in postoperative pain control is well established, limited evidence exists regarding its impact on gastrointestinal function, particularly in the context of bariatric surgery.
Study Objective:
The primary objective of this study is to evaluate whether the application of ultrasound-guided TAP block affects postoperative gastrointestinal function after laparoscopic sleeve gastrectomy. Gastrointestinal recovery will be assessed using the PRO-diGI scale, which captures patient-reported symptoms of gastrointestinal motility, and the Perlas gastric ultrasound score, which provides an objective estimate of gastric content and residual volume.
Study Design:
This is a prospective, single-center clinical study conducted at Elazığ Fethi Sekin City Hospital. Adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. All participants will receive standardized general anesthesia. TAP block will be administered as part of the perioperative analgesia strategy in eligible patients, based on clinical decision-making and patient consent.
Assessments:
Primary Outcome:
PRO-diGI score measured at predefined postoperative intervals (e.g., 6, 24, and 48 hours after surgery).
Secondary Outcomes:
Perlas score obtained via gastric ultrasonography in the early postoperative period.
Postoperative opioid consumption within the first 48 hours.
Incidence of postoperative nausea, vomiting, and ileus.
Length of hospital stay.
Ethics and Compliance:
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Ethical approval has been obtained from the institutional review board. Written informed consent will be obtained from all participants prior to study inclusion.
Expected Impact:
By integrating both subjective and objective measures of gastrointestinal function, this study will provide high-quality evidence regarding the potential benefits of TAP block beyond pain control. The results may contribute to optimizing perioperative care strategies for bariatric surgery and improving patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block Group | – | Procedure: TAP Block GroupPatients receiving bilateral ultrasound-guided TAP block at the end of laparoscopic sleeve gastrectomy as part of multimodal analgesia. |
| Control Group | – | Procedure: Control GroupPatients receiving standard multimodal analgesia without TAP block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective laparoscopic sleeve gastrectomy at Elazığ Fethi Sekin City Hospital. Both male and female patients who meet inclusion criteria and consent to participate will be enrolled consecutively.
Key inclusion criteria (5 listed)
- Adult patients aged 18-65 years
- Scheduled for primary laparoscopic sleeve gastrectomy (LSG)
- Body Mass Index (BMI) ≥ 35 kg/m²
- ASA Physical Status II-III
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Previous major abdominal surgery
- Known allergy to local anesthetics
- Severe hepatic or renal dysfunction
- Pregnancy or breastfeeding
- Conversion to open surgery during the procedure
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 |
|---|---|---|
| TAP Block GroupBilateral ultrasound-guided transversus abdominis plane block performed at the end of surgery using 20 mL of 0.25% bupivacaine per side. | Procedure or surgery | TAP Block Group |
| Control GroupStandard ERAS-based multimodal analgesia protocol without regional block. | Procedure or surgery | Control Group |
Primary outcome
Postoperative Gastrointestinal Function
Time frame: Postoperative 6, 12, 24, and 48 hours
Description: Assessed using the validated Patient-Reported Outcome for Dysfunction in Gastrointestinal Recovery after Surgery (PRO-diGI) scale, which captures patient-reported symptoms of gastrointestinal motility, including nausea, vomiting, bloating, and oral intake tolerance. The scale ranges from 0 to 15, with higher scores indicating greater gastrointestinal dysfunction and worse postoperative GI function.
4 secondary outcomes
Perlas Score
Time frame: Preoperative and immediate postoperative period
Opioid Consumption
Time frame: First 48 hours postoperatively
Pain Scores (NRS)
Time frame: 2, 6, 12, 24, and 48 hours postoperatively
Adverse Events
Time frame: From immediately after surgery up to 7 days 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 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Obesity and Postoperative Gastrointestinal Dysfunction, run by Elazıg Fethi Sekin Sehir Hastanesi 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 5 inclusion and 6 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 11 Sep 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?
Contact Serpil Bayındır, Specialist Physician/Anesthesi (+905055493582, serpilbayindir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Gastrointestinal Function (time frame: Postoperative 6, 12, 24, and 48 hours). 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 11 Sep 2025.