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Clinical Trials/NCT05939635
NCT05939635
Completed
Not Applicable

Bilateral Ultrasound-guided M-Tapa Block vs External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study

Ondokuz Mayıs University1 site in 1 country66 target enrollmentJuly 11, 2023

Overview

Phase
Not Applicable
Intervention
Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
Conditions
Anesthesia
Sponsor
Ondokuz Mayıs University
Enrollment
66
Locations
1
Primary Endpoint
Morphine consumption in the first 24 hours after surgery
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

In obese patients, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea, vomiting, and analgesia. This study aimed to investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy.

Detailed Description

Morbid obesity patients often have multisystem physiological changes and multiple comorbidities that can significantly affect perioperative pain control. These patients may have increased side effects from inadequate acute pain management and opioids should be used with caution. Regional techniques can be applied in obese patients because they provide non-opioid analgesia and have fewer perioperative respiratory side effects. Effective pain control is associated with reduced post-operative opioid administration, faster mobilization, faster recovery, and shorter hospital stay. Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Recently, it has been reported that the M-TAPA block is a promising new technique that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is delivered only to the underside of the perichondral surface. TAPA/M-TAPA block has been shown to provide a potent analgesic effect in a large abdomen by numbing both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. Therefore, the TAPA/M-TAPA block has been used in various abdominal surgeries. The EOI block represents an important modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall. When we look at the literature, it is seen that there are not enough studies on M-TAPA block and EOIB. The aim of this study is to investigate the effects of Bilateral External Oblique Intercostal Block (EOIB) and Perichondrial Modified Thoracoabdominal Nerve Block (M-TAPA) on postoperative acute pain scores (0-24 hours) and 24-hour opioid consumption in patients who underwent laparoscopic sleeve gastrectomy. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, parallel-group study. Patients will be divided into two groups: Group M-TAPA : A bilateral M-TAPA (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours. Group EOIB : A bilateral EOIB (60 ml 0.25% bupivacaine + 1:400.000 adrenaline) will be performed. In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Registry
clinicaltrials.gov
Start Date
July 11, 2023
End Date
January 29, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

BURHAN DOST

Associate Professor

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Age between18-65 years
  • American Society of Anesthesiology score II-III
  • Body mass index (BMI) \> 35 kg/m2
  • Patients who will sign the informed consent form

Exclusion Criteria

  • History of opioid use for more than four weeks
  • Chronic pain syndromes
  • Patients with a history of local anesthetic or opioid allergy, hypersensitivity
  • Severe cardiac, hepatic, and renal disease
  • Alcohol and drug addiction
  • Conditions where regional anesthesia is contraindicated
  • Failure in the dermatomal examination performed after the block
  • Patients with a STOP-BANG score ≥5

Arms & Interventions

Group M-TAPA

A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Intervention: Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block

Group M-TAPA

A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Intervention: IV morphine patient-controlled analgesia (PCA)

Group EOIB

A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Intervention: Bilateral ultrasound guided external oblique intercostal block (EOIB)

Group EOIB

A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Intervention: IV morphine patient-controlled analgesia (PCA)

Outcomes

Primary Outcomes

Morphine consumption in the first 24 hours after surgery

Time Frame: Postoperative day 1

Morphine consumption in the first 24 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is≥ 4.

Secondary Outcomes

  • The number of patients with complications(Postoperative 7 days on an average)
  • Postoperative pain scores(Postoperative day 1)
  • Patients' satisfaction and quality of pain management(Postoperative day 1)
  • The incidences of postoperative nausea and vomiting (PONV)(Postoperative day 1)
  • Time of first analgesic request(Postoperative day 1)
  • Intraoperative remifentanil consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.)
  • The number of patients who required rescue analgesia.(Postoperative day 1)

Study Sites (1)

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