M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Sleeve Gastrectomy Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anesthesia, Regional Anesthesia, Postoperative Pain

Intervention / Treatment
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* Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)
* Procedure: Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
* Drug: IV morphine patient-controlled analgesia (PCA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group M-TAPA<br>A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA) | Procedure: Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block<br>* 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.<br>* Other names: M-TAPA block;Drug: IV morphine patient-controlled analgesia (PCA)<br>* Morphine will be administered via PCA device for the first 24 hours after surgery<br>* Other names: morphine PCA;|
| Active Comparator: Group EOIB<br>A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA) | Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)<br>* 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.<br>* Other names: External oblique intercostal block (EOIB);Drug: IV morphine patient-controlled analgesia (PCA)<br>* Morphine will be administered via PCA device for the first 24 hours after surgery<br>* Other names: morphine PCA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption in the first 24 hours after surgery | 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. | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Pain status at rest and while activity will be assessed by NRS score at 0, 3, 6, 12, 18, and 24 hours after surgery. The NRS is an 11-point numeric scale that ranges from 0 to 10. | Postoperative day 1 | 
| Patients' satisfaction and quality of pain management | Patients' pain management satisfaction and quality will be evaluated using the QoR-15 score. The QoR-15 consists of 5 test areas: pain (2 questions), physical comfort (5 questions), physical state (2 questions), psychological state (2 questions), and emotional state (4 questions). Each question is rated on a 10-point scale ranging from 0 = never to 10 = always (scoring is reversed for negative questions). QoR-15 Turkish Version will be used for assessment. | Postoperative day 1 | 
| The incidences of postoperative nausea and vomiting (PONV) | The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once. | Postoperative day 1 | 
| Time of first analgesic request | Time at which the first analgesic is requested | Postoperative day 1 | 
| Intraoperative remifentanil consumption | The total amount of remifentanil consumed will be recorded. | 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 with complications | The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded | Postoperative 7 days on an average | 
| The number of patients who required rescue analgesia. | he number of patients requiring rescue analgesics will be recorded over 24 hours. | Postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Nerve block, Sleeve gastrectomy, External oblique intercostal block