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Clinical Trials/NCT05822479
NCT05822479
Completed
Not Applicable

Bilateral Ultrasound-guided External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study

Ondokuz Mayıs University1 site in 1 country60 target enrollmentApril 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Ondokuz Mayıs University
Enrollment
60
Locations
1
Primary Endpoint
Cumulative opioid consumption in the first 24 hours after surgery
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2023
End Date
May 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Cengiz KAYA

Principal Investigator, Clinical Professor

Ondokuz Mayıs University

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

  • Patients with drug allergies (Opioids, NSAIDs, local anesthetics)
  • Patients with neuro-psychiatric disease, cognitive impairment, inability to communicate, or a history of drug addiction
  • Presence of any systemic infection or at the injection site
  • Patients taking anticoagulants or having any bleeding disorder (Coagulopathy, International Normalized Ratio (INR) value not within normal limits, thrombocytopenia or platelet dysfunction)
  • Patients with significant cardiovascular, hepatic, renal or endocrine disorders
  • Patients with a history of chronic pain syndromes or receiving chronic pain treatment and a history of opioid use for more than four weeks in the preoperative period
  • Patients using continuous positive airway pressure device due to obstructive sleep apnea syndrome (OSAS) (symptoms detected by polysomnography and apnea-hypopnea index (AHI) \>5/hour)
  • Patients with chronic obstructive pulmonary disease
  • Patients who need intensive care unit after surgery
  • Patients who do not consent/do not want to participate

Outcomes

Primary Outcomes

Cumulative opioid consumption in the first 24 hours after surgery

Time Frame: postoperative day 1

Cumulative opioid 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. In cases where rescue analgesia is required (NRS score ≥4), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.

Secondary Outcomes

  • 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 number of patients with complications(Postoperative 7 days on an average)
  • 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, up to 180 minutes.)
  • The scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.(postoperative day 1)
  • Patients' satisfaction and quality of pain management(postoperative day 1)
  • 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.)
  • Cumulative opioid consumption in the first 12 hours after surgery(postoperative day 1)
  • Postoperative pain scores(postoperative day 1)
  • The number of patients who required rescue analgesia.(postoperative day 1)
  • Time of first analgesic request(postoperative day 1)

Study Sites (1)

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