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NCT Number: NCT05822479

Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

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.

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Key information

Conditions

Anesthesia Body Weight Morbid Obesity Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Regional Anesthesia Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral ultrasound guided external oblique intercostal block (EOIB)

Procedure

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, iv paracetamol 1 gr and iv morphine 0.05 mg/kg/ideal body weight (IBW) 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 10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). Rescue analgesia, when necessary (if the resting NRS score is ≥4 despite PCA demand), 25 mg IV meperidine was administered in the recovery unit, and 50 mg intramuscular (IM) meperidine was administered in the ward.

Other names: External oblique intercostal block

Control

Other

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, iv paracetamol 1 gr and iv morphine 0.05 mg/kg/ideal body weight (IBW) 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 10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). Rescue analgesia, when necessary (if the resting NRS score is ≥4 despite PCA demand), 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.

Primary outcomes

  1. 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

  1. Cumulative opioid consumption in the first 12 hours after surgery

    Time frame: postoperative day 1

    Cumulative opioid consumption in the first 12 hours after surgery will be measured. Patients can request opioids via a PCA device when their NRS score is ≥4 and 25 mg IV meperidine was administered in the recovery unit, and 50 mg IM meperidine was administered in the ward.

  2. Postoperative pain scores

    Time frame: 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.

  3. Patients' satisfaction and quality of pain management

    Time frame: 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.

  4. The scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.

    Time frame: 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. For PONV prophylaxis, patients will be routinely administered 8 mg IV dexamethasone before induction and 0.15 mg/kg (IVA) IV ondansetron 20 minutes before the end of the procedure. If a score of 3 or more is recorded, 4 mg IV ondansetron will be administered and repeated after 4 hours if required. Despite the administration of ondansetron, if the score is ≥3, the patients will be administered 10 mg IV metoclopramide diluted in 100 ml saline solution as an IV infusion. The number of patients who receive antiemetic treatment will be recorded. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

  5. The number of patients who required rescue analgesia.

    Time frame: postoperative day 1

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

  6. Time of first analgesic request

    Time frame: postoperative day 1

    Time at which the first analgesic is requested

  7. Intraoperative remifentanil consumption

    Time frame: 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.

  8. The number of patients with complications

    Time frame: 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

  9. 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.

  10. The mean arterial pressure measurement

    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.

    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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 20, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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