Clinical trial

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

Name

MTAPAEOIBLSG2023

Description

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.

Trial arms

Trial start

2023-07-11

Estimated PCD

2023-10-26

Trial end

2024-01-29

Status

Completed

Treatment

Bilateral ultrasound guided external oblique intercostal block (EOIB)

Bilateral ultrasound-guided EOIB (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, and iv paracetamol 1 gr and 0.05 mg/kg, ideal body weight (IBW), iv morphine will be administered. End of the surgery, hyoscine-N-butyl bromide will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5 mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). In cases where rescue analgesia is required (NRS score ≥4), 50 mg of meperidine is administered to patients. Patients are routinely administered ondansetron 8 mg IV 20 minutes before extubation for postoperative nausea and vomiting prophylaxis.

Arms:

Group EOIB

Other names:

External oblique intercostal block (EOIB)

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

Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Patients are administered iv tenoxicam 20mg and tramadol 100 mg after induction of general anesthesia, and iv paracetamol 1 gr and 0.05 mg/kg, ideal body weight (IBW), iv morphine will be administered. End of the surgery, hyoscine-N-butyl bromide will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5 mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). In cases where rescue analgesia is required (NRS score ≥4), 50 mg of meperidine is administered to patients. Patients are routinely administered ondansetron 8 mg IV 20 minutes before extubation for postoperative nausea and vomiting prophylaxis.

Arms:

Group M-TAPA

Other names:

M-TAPA block

IV morphine patient-controlled analgesia (PCA)

Morphine will be administered via PCA device for the first 24 hours after surgery

Arms:

Group EOIB, Group M-TAPA

Other names:

morphine PCA

Size

Primary endpoint

Morphine consumption in the first 24 hours after surgery

Postoperative day 1

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Researchers, surgeons and nurses, and those involved in study outcome analysis will not be aware of the randomization of the group. Block quality and standardization will be performed by an anesthetist experienced in regional anesthesia for EOIB and M-TAPA block.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

Updated at

2024-01-30

1 organization

1 product

3 indications

Organization

Ondokuz Mayıs University

Product

Indication

Indication

Indication