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NCT Number: NCT06934772

Comparison of the Analgesic Efficacy of Subcostal TAP and M-TAPA Blocks in Laparoscopic Sleeve Gastrectomy Surgery

Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a Body mass index (BMI) greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).

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Key information

Conditions

Plane Block Agnosia Bariatric Surgery Bites and Stings Chemically-Induced Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Poisoning Regional Anaesthesia Signs and Symptoms Transversus Abdominis Plane (TAP) Block Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

About this study

Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).

Study Design This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a BMI greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).

Study Procedures Patients who meet the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.

Outcome Measures

  • Primary Outcome: Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods (first 24 hours).
  • Secondary Outcomes: Resting and active NRS pain scores, mobilization times, incidence of nausea and vomiting, and complications related to the block procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with a BMI greater than 35 kg/m²,
  • aged between 18 and 65, who are scheduled to undergo LSG surgery.
  • Patients will receive either a subcostal TAP or M-TAPA block before surgery. Exclusion Criteria:
  • patients with incomplete data
  • patients with chronic pain
  • patients with preoperative opioid use
  • patients with preoperative alcohol/substance use

Treatment and study plan

M-TAPA

Other

this study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).

Subcostal TAP

Other

this study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).

Primary outcomes

  1. Analgesic Efficacy

    Time frame: Intraoperative periods, postoperative first 24 hours.

    Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods.The visual pain score includes values between 0 and 10. o means no pain, 5 means moderate pain, and 10 means severe pain. In the postoperative period, the pain levels of the patients will be compared by looking at this visual pain value. In the intraoperative period, the amount of analgesic consumption (total consumption of remifentanil mcg) will be evaluated.

Secondary outcomes

  1. Other conditions associated with the block

    Time frame: postoperative 24 hours

    Resting and active NRS pain scores, mobilization times, nausea and vomiting frequency and complications related to block procedures. Visual pain scores of patients when they first start moving postoperatively will be examined. 0 is evaluated as no pain, 5 as moderate pain, 10 as very severe pain. The time they first started mobilizing will be determined according to the postoperative hour. It will be recorded as whether nausea and vomiting occurred or not. If there were other complications (e.g. bleeding at the block site, hematoma, shortness of breath, pneumothorax), all this information will be determined from the patient files.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Comparison of the Analgesic Efficacy of Subcostal Transversus Abdominis Plane and Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Blocks in Laparoscopic Sleeve Gastrectomy Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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