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

NCT07168538 | Not Yet Recruiting

• 1 other identifier: FSCH-SBÜ-2025/092
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Postoperative Gastrointestinal Dysfunction

Keywords

TAP Block; Gastrointestinal Motility; PRO-diGI Scale; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative 6, 12, 24, and 48 hours

Secondary Outcomes (4)

• Perlas Score

  Preoperative and immediate postoperative period

• Opioid Consumption

  First 48 hours postoperatively

• Pain Scores (NRS)

  2, 6, 12, 24, and 48 hours postoperatively

• Adverse Events

  From immediately after surgery up to 7 days postoperatively

Study Arms (2)

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

Control Group

Patients receiving standard multimodal analgesia without TAP block.

Procedure: Control Group

Interventions

TAP Block Group PROCEDURE

Bilateral ultrasound-guided transversus abdominis plane block performed at the end of surgery using 20 mL of 0.25% bupivacaine per side.

TAP Block Group

Control Group PROCEDURE

Standard ERAS-based multimodal analgesia protocol without regional block.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Serpil Bayındır, Specialist Physician/Anesthesi

CONTACT

+905055493582; serpilbayindir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

TU (1)