Effect of TAP Block on GI Function After Sleeve Gastrectomy Using PRO-diGI Scale and Perlas Score (TAP)

September 9, 2025 updated by: Elazıg Fethi Sekin Sehir Hastanesi

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TAP Block Group
Patients receiving bilateral ultrasound-guided TAP block at the end of laparoscopic sleeve gastrectomy as part of multimodal analgesia.
Procedure: TAP Block Group
Bilateral ultrasound-guided transversus abdominis plane block performed at the end of surgery using 20 mL of 0.25% bupivacaine per side.
Control Group
Patients receiving standard multimodal analgesia without TAP block.
Procedure: Control Group
Standard ERAS-based multimodal analgesia protocol without regional block.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Postoperative 6, 12, 24, and 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perlas Score
Time Frame: Preoperative and immediate postoperative period
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.
Preoperative and immediate postoperative period
Opioid Consumption
Time Frame: First 48 hours postoperatively
Total opioid use in morphine milligram equivalents.
First 48 hours postoperatively
Pain Scores (NRS)
Time Frame: 2, 6, 12, 24, and 48 hours postoperatively
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.
2, 6, 12, 24, and 48 hours postoperatively
Adverse Events
Time Frame: From immediately after surgery up to 7 days postoperatively
Incidence of postoperative nausea, vomiting, ileus, or TAP block-related complications.
From immediately after surgery up to 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elazıg Fethi Sekin Sehir Hastanesi

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FSCH-SBÜ-2025/092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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