Clinical trial NCT05822479: Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block
Official title: Bilateral Ultrasound-guided External Oblique Intercostal Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Regional Anesthesia
Morbid Obesity
Postoperative Pain
Keywords: Anesthesia
Nerve block
Obesity
Laparoscopy
External oblique intercostal block
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)'.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative opioid consumption in the first 24 hours after surgery
timeFrame: postoperative day 1
Secondary outcomes:
measure: Cumulative opioid consumption in the first 12 hours after surgery
timeFrame: postoperative day 1
measure: Postoperative pain scores
timeFrame: postoperative day 1
measure: Patients' satisfaction and quality of pain management
timeFrame: postoperative day 1
measure: The scores of postoperative nausea and vomiting (PONV) and the number of patients requiring postoperative antiemetics.
timeFrame: postoperative day 1
measure: The number of patients who required rescue analgesia.
timeFrame: postoperative day 1
measure: Time of first analgesic request
timeFrame: postoperative day 1
measure: Intraoperative remifentanil consumption
timeFrame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.
measure: The number of patients with complications
timeFrame: Postoperative 7 days on an average
measure: The heart rate measurement
timeFrame: 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.
measure: The mean arterial pressure measurement
timeFrame: 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.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: Cengiz KAYA
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.