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Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

O

Ondokuz Mayıs University

Status

Completed

Conditions

Postoperative Pain
Morbid Obesity
Regional Anesthesia
Anesthesia

Treatments

Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT05822479
EOIB2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age between18-65 years
  2. American Society of Anesthesiology score II-III
  3. Body mass index (BMI) > 35 kg/m2
  4. Patients who will sign the informed consent form

Exclusion criteria

  1. Patients with drug allergies (Opioids, NSAIDs, local anesthetics)
  2. Patients with neuro-psychiatric disease, cognitive impairment, inability to communicate, or a history of drug addiction
  3. Presence of any systemic infection or at the injection site
  4. Patients taking anticoagulants or having any bleeding disorder (Coagulopathy, International Normalized Ratio (INR) value not within normal limits, thrombocytopenia or platelet dysfunction)
  5. Patients with significant cardiovascular, hepatic, renal or endocrine disorders
  6. 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
  7. 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)
  8. Patients with chronic obstructive pulmonary disease
  9. Patients who need intensive care unit after surgery
  10. Patients who do not consent/do not want to participate

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Group EOIB
Active Comparator group
Description:
A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)
Treatment:
Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)
Group Control
Other group
Description:
IV morphine PCA
Treatment:
Other: Control

Trial contacts and locations

1

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Central trial contact

ELİF SARIKAYA ÖZEL, MD; CENGİZ KAYA, MD

Data sourced from clinicaltrials.gov

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