Effect of TAP Block on GI Function After Sleeve Gastrectomy Using PRO-diGI Scale and Perlas Score
NCT ID: NCT07168538
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2025-09-01
2025-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TAP Block Group
Patients receiving bilateral ultrasound-guided TAP block at the end of laparoscopic sleeve gastrectomy as part of multimodal analgesia.
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.
Control Group
Standard ERAS-based multimodal analgesia protocol without regional block.
Interventions
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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
Standard ERAS-based multimodal analgesia protocol without regional block.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Elazıg Fethi Sekin Sehir Hastanesi
OTHER
Responsible Party
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Locations
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Elazığ Fethi Sekin City Hospital
Elâzığ, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FSCH-SBÜ-2025/092
Identifier Type: -
Identifier Source: org_study_id
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