Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Morbid Obesity; Anesthesia; Regional Anesthesia
• Intervention / Treatment: Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB); Other: Control

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Atakum
    • Samsun, Atakum, Turkey, 55139
      • Ondokuz Mayis Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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, 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
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, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative opioid consumption in the first 24 hours after surgery	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.	postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	postoperative day 1
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.	postoperative day 1
The number of patients who required rescue analgesia.	The number of patients requiring rescue analgesics will be recorded over 24 hours.	postoperative day 1
Time of first analgesic request	Time at which the first analgesic is requested	postoperative day 1
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	Postoperative 7 days on an average
Intraoperative remifentanil consumption	The total amount of remifentanil consumed will be recorded.	The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
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.	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 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 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.
Cumulative opioid consumption in the first 12 hours after surgery	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.	postoperative day 1
The scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.	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.	postoperative day 1

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Anesthesia; Laparoscopy; Nerve block; External oblique intercostal block
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: EOIB2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No