Effect of TAP Block on GI Function After Sleeve Gastrectomy Using PRO-diGI Scale and Perlas Score
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorElazıg Fethi Sekin Sehir Hastanesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous major abdominal surgery
Known allergy to local anesthetics
Severe hepatic or renal dysfunction
Pregnancy or breastfeeding
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TAP Block Group
Procedure/SurgeryBilateral ultrasound-guided transversus abdominis plane block performed at the end of surgery using 20 mL of 0.25% bupivacaine per side.
Control Group
Procedure/SurgeryStandard ERAS-based multimodal analgesia protocol without regional block.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TAP Block Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
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.
Time frame
Postoperative 6, 12, 24, and 48 hoursSecondary outcomes
1
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.
Time frame
Preoperative and immediate postoperative period2
Opioid Consumption
Total opioid use in morphine milligram equivalents.
Time frame
First 48 hours postoperatively3
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.
Time frame
2, 6, 12, 24, and 48 hours postoperatively4
Adverse Events
Incidence of postoperative nausea, vomiting, ileus, or TAP block-related complications.
Time frame
From immediately after surgery up to 7 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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