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Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

Primary Purpose

Anesthesia, Regional Anesthesia, Morbid Obesity

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral ultrasound guided external oblique intercostal block (EOIB)
Control
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia focused on measuring Anesthesia, Nerve block, Obesity, Laparoscopy, 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 Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Group EOIB

Group Control

Arm Description

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

IV morphine 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 Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version.
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.
The number of patients who required rescue analgesia.
The number of patients requiring rescue analgesics will be recorded over 24 hours.
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 heart rate measurement
The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
The mean arterial pressure measurement
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

Full Information

First Posted
April 10, 2023
Last Updated
June 23, 2023
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05822479
Brief Title
Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block
Official Title
Bilateral Ultrasound-guided 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
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
December 10, 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 evaluate the impact of the external oblique intercostal block postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic sleeve gastrectomy surgery.
Detailed Description
Adequate pain control in laparoscopic surgeries is associated with reduced postoperative opioid administration, faster mobilization, faster recovery, and shorter hospital stays. Intraoperative nerve blocks using local anesthetics have been shown to improve postoperative pain in various abdominal surgeries, both open and laparoscopic. Laparoscopic bariatric procedures are most often associated with moderate to severe visceral pain from surgical manipulation of the stomach and intestine. Combined regional and general anesthesia reduces surgical stress responses by interrupting pain transmission signals, which facilitates pain control, reduces opioid consumption, and improves patient postoperative satisfaction. Ultrasound-guided fascial plane blocks have been rapidly included in regional anesthesia applications as an alternative to neuraxial techniques in recent years and include injection into a tissue plane to provide analgesia in various anatomical areas. The external oblique intercostal block (EOIB) represents an essential modification of the fascial plane block techniques that can consistently cover the upper lateral abdominal wall. The EOIB block has easily identifiable sonographic points. The study aims to investigate the effects of the EOIB on postoperative pain in morbidly obese patients who will undergo laparoscopic sleeve gastrectomy by comparing it with the control group. It is seen that there are not enough studies on EOIB in the literature. Our study, which the investigators think will contribute to the literature, was planned as a prospective, randomized, controlled, single-blind, parallel-group study. Patients will be divided into two groups: 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. Group Control: Patients in this group will not receive any block. 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, Morbid Obesity, Postoperative Pain
Keywords
Anesthesia, Nerve block, Obesity, Laparoscopy, External oblique intercostal block

7. Study Design

Primary Purpose
Supportive Care
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, 'Research Randomizer (Urbaniak and Plous, 2013)'.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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)
Arm Title
Group Control
Arm Type
Other
Arm Description
IV morphine PCA
Intervention Type
Procedure
Intervention Name(s)
Bilateral ultrasound guided external oblique intercostal block (EOIB)
Other Intervention Name(s)
External oblique intercostal block
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 0,5mg/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
Other
Intervention Name(s)
Control
Intervention Description
Patients in this group will not be performed interfacial plane blocks. 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 (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 0,5mg/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.
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 Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version.
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
The number of patients who required rescue analgesia.
Description
The number of patients requiring rescue analgesics will be recorded over 24 hours.
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 heart rate measurement
Description
The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
Time Frame
Time Frame: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.
Title
The mean arterial pressure measurement
Description
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.
Time Frame
The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 180 minutes.

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cengiz KAYA
Organizational Affiliation
Ondokuz Mayıs University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayis Universitesi
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30170687
Citation
Saber AA, Lee YC, Chandrasekaran A, Olivia N, Asarian A, Al-Ayoubi S, DiGregorio R. Efficacy of transversus abdominis plane (TAP) block in pain management after laparoscopic sleeve gastrectomy (LSG): A double-blind randomized controlled trial. Am J Surg. 2019 Jan;217(1):126-132. doi: 10.1016/j.amjsurg.2018.07.010. Epub 2018 Aug 1.
Results Reference
background
PubMed Identifier
34626112
Citation
Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
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
31175560
Citation
Coskun M, Yardimci S, Arslantas MK, Altun GT, Uprak TK, Kara YB, Cingi A. Subcostal Transversus Abdominis Plane Block for Laparoscopic Sleeve Gastrectomy, Is It Worth the Time? Obes Surg. 2019 Oct;29(10):3188-3194. doi: 10.1007/s11695-019-03984-4.
Results Reference
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Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

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