Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05822479
Collaborator
(none)
60
1
2
7.7
7.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)
  • Other: Control
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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)'.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:
Triple (Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Supportive Care
Official Title:
Bilateral Ultrasound-guided External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Sep 20, 2023
Anticipated Study Completion Date :
Dec 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group EOIB

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

Procedure: 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 0,5mg/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.
Other Names:
  • External oblique intercostal block
  • Other: Group Control

    IV morphine PCA

    Other: Control
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Morphine consumption in the first 24 hours after surgery [postoperative day 1]

      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

    1. Postoperative pain scores [postoperative day 1]

      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.

    2. Patients' satisfaction and quality of pain management [postoperative day 1]

      Patients' pain management satisfaction and quality will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version.

    3. The incidences of postoperative nausea and vomiting (PONV) [postoperative day 1]

      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.

    4. The number of patients who required rescue analgesia. [postoperative day 1]

      The number of patients requiring rescue analgesics will be recorded over 24 hours.

    5. Time of first analgesic request [postoperative day 1]

      Time at which the first analgesic is requested

    6. 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.]

      The total amount of remifentanil consumed will be recorded.

    7. The number of patients with complications [Postoperative 7 days on an average]

      The number of patients has any complications -directly related to the block or the drug used in the block- will be recorded

    8. The heart rate measurement [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.]

      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.

    9. 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, up to 180 minutes.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ondokuz Mayis Universitesi Samsun Atakum Turkey 55139

    Sponsors and Collaborators

    • Ondokuz Mayıs University

    Investigators

    • Study Director: Cengiz KAYA, Ondokuz Mayıs University Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Cengiz KAYA, Principal Investigator, Clinical Professor, Ondokuz Mayıs University
    ClinicalTrials.gov Identifier:
    NCT05822479
    Other Study ID Numbers:
    • EOIB2022
    First Posted:
    Apr 20, 2023
    Last Update Posted:
    Apr 21, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cengiz KAYA, Principal Investigator, Clinical Professor, Ondokuz Mayıs University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 21, 2023