Laparoscopic Sleeve Gastrectomy Surgery and External Oblique Intercostal Block

NCT05822479 | Completed

• 1 other identifier: EOIB2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Regional Anesthesia; Morbid Obesity; Postoperative Pain

Keywords

Anesthesia; Nerve block; Obesity; Laparoscopy; External oblique intercostal block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Cumulative opioid consumption in the first 12 hours after surgery

  postoperative day 1

• Postoperative pain scores

  postoperative day 1

• Patients' satisfaction and quality of pain management

  postoperative day 1

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

  postoperative day 1

• The number of patients who required rescue analgesia.

  postoperative day 1

Study Arms (2)

Group EOIB

ACTIVE COMPARATOR

A bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

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

Group Control

OTHER

IV morphine PCA

Other: Control

Interventions

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.

Also known as: External oblique intercostal block

Group EOIB

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.

Group Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 30170687 BACKGROUND

• 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.

  PMID: 34626112 BACKGROUND

• 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.

  PMID: 35249704 BACKGROUND

• 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.

  PMID: 31175560 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Pain, Postoperative; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Cengiz KAYA

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist administering the block/blocks about which group the patient is in immediately before administration. Researchers, surgeons, and nurses will not be aware of the randomization of groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: 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)'.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 20, 2023
• Study Start: April 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: May 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)