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

NCT05939635 | Completed

• 1 other identifier: MTAPAEOIBLSG2023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Regional Anesthesia; Postoperative Pain

Keywords

Anesthesia; Nerve block; Sleeve gastrectomy; External oblique intercostal block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

Study Arms (2)

Group M-TAPA

ACTIVE COMPARATOR

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; Drug: IV morphine patient-controlled analgesia (PCA)

Group EOIB

ACTIVE COMPARATOR

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

Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB); Drug: IV morphine patient-controlled analgesia (PCA)

Interventions

Bilateral ultrasound guided external oblique intercostal block (EOIB) PROCEDURE

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.

Also known as: External oblique intercostal block (EOIB)

Group EOIB

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

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.

Also known as: M-TAPA block

Group M-TAPA

IV morphine patient-controlled analgesia (PCA) DRUG

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

Also known as: morphine PCA

Group EOIB; Group M-TAPA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (4)

• Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.

  PMID: 36575362 BACKGROUND

• White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.

  PMID: 35249704 BACKGROUND

• Erskine RN, White L. "A review of the external oblique intercostal plane block - a novel approach to analgesia for upper abdominal surgery". J Clin Anesth. 2022 Nov;82:110953. doi: 10.1016/j.jclinane.2022.110953. Epub 2022 Aug 19. No abstract available.

  PMID: 35994942 BACKGROUND

• Ibrahim M, Elnabtity AM, Hegab A, Alnujaidi OA, El Sanea O. Combined opioid free and loco-regional anaesthesia enhances the quality of recovery in sleeve gastrectomy done under ERAS protocol: a randomized controlled trial. BMC Anesthesiol. 2022 Jan 21;22(1):29. doi: 10.1186/s12871-021-01561-w.

  PMID: 35062872 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Burhan DOST, Md

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 11, 2023
• Study Start: July 11, 2023
• Primary Completion: October 26, 2023
• Study Completion: January 29, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

TU (1)