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

Primary Purpose

Anesthesia, Regional Anesthesia, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral ultrasound guided external oblique intercostal block (EOIB)
Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
IV morphine patient-controlled analgesia (PCA)
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Anesthesia, Nerve block, Sleeve gastrectomy, External oblique intercostal block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ondokuz Mayis UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group M-TAPA

Group EOIB

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Time of first analgesic request
Time at which the first analgesic is requested
Intraoperative remifentanil consumption
The total amount of remifentanil consumed will be recorded.
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
The number of patients who required rescue analgesia.
he number of patients requiring rescue analgesics will be recorded over 24 hours.

Full Information

First Posted
June 23, 2023
Last Updated
July 12, 2023
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05939635
Brief Title
M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Sleeve Gastrectomy Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
August 26, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Regional Anesthesia, Postoperative Pain
Keywords
Anesthesia, Nerve block, Sleeve gastrectomy, External oblique intercostal block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group M-TAPA
Arm Type
Active Comparator
Arm Description
A bilateral M-TAPA (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
Arm Title
Group EOIB
Arm Type
Active Comparator
Arm Description
A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
Intervention Type
Procedure
Intervention Name(s)
Bilateral ultrasound guided external oblique intercostal block (EOIB)
Other Intervention Name(s)
External oblique intercostal block (EOIB)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
Other Intervention Name(s)
M-TAPA block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IV morphine patient-controlled analgesia (PCA)
Other Intervention Name(s)
morphine PCA
Intervention Description
Morphine will be administered via PCA device for the first 24 hours after surgery
Primary Outcome Measure Information:
Title
Morphine consumption in the first 24 hours after surgery
Description
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.
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
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.
Time Frame
Postoperative day 1
Title
Patients' satisfaction and quality of pain management
Description
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.
Time Frame
Postoperative day 1
Title
The incidences of postoperative nausea and vomiting (PONV)
Description
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.
Time Frame
Postoperative day 1
Title
Time of first analgesic request
Description
Time at which the first analgesic is requested
Time Frame
Postoperative day 1
Title
Intraoperative remifentanil consumption
Description
The total amount of remifentanil consumed will be recorded.
Time Frame
The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
Title
The number of patients with complications
Description
The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded
Time Frame
Postoperative 7 days on an average
Title
The number of patients who required rescue analgesia.
Description
he number of patients requiring rescue analgesics will be recorded over 24 hours.
Time Frame
Postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burhan Dost, Md
Phone
05327042493
Email
burhandost@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Turunç, Md
Phone
05074341884
Email
esra.kiymaz.ek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burhan DOST, Md
Organizational Affiliation
Ondokuz Mayıs University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayis University
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burhan Dost, Md

12. IPD Sharing Statement

Citations:
PubMed Identifier
36575362
Citation
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.
Results Reference
background
PubMed Identifier
35249704
Citation
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.
Results Reference
background
PubMed Identifier
35994942
Citation
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.
Results Reference
background
PubMed Identifier
35062872
Citation
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.
Results Reference
background

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

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