EOI Block Versus ESP Block in Laparoscopic Bariatric Surgery

NCT06168903 | Recruiting

• 1 other identifier: N-402-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare a single shot of bilateral ultrasound-guided EOI block and ESPB in terms of intraoperative opioid consumption, postoperative pain control in the first 24 hours, and the need for rescue analgesics.

Conditions

Anesthesia; Bariatric Surgery Candidate; Regional Anesthesia Morbidity

Keywords

External oblique intercostal; Erector spinae Block; Bariatric; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Visual analogue pain score

  VAS Score at rest (static) and on movement (dynamic) at 2, 4, 6, 12, 18, and 24 hours postoperatively

  24 hours

Secondary Outcomes (6)

• Time needed to perform the block

  30-60 Minutes

• Fentanyl consumption

  Up to 4 hours

• Total morphine requirements

  24 hours

• First postoperative analgesic request

  24 hours

• Postoperative nausea and vomiting

  24 hours

Study Arms (2)

EOI block Group (n=25):bilateral US-guided external oblique intercostal block.

EXPERIMENTAL

Patient in a supine position. A linear ultrasound probe will be placed in paramedian sagittal orientation between the midclavicular and anterior axillary lines at the level of the sixth rib, visualizing the external oblique and intercostal muscles. Local anesthetics are injected under the external oblique muscle. A 22-gauge needle will be advanced in the superomedial-to-inferolateral direction into the fascial plane between the external oblique and intercostal muscles at the caudal end of the sixth rib and between the sixth and seventh ribs.The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.25% will be injected in the fascial plane incrementally, aspirating every 5 ml, and the block will be repeated on the other side.

Procedure: Ultrasound guided EOI block

ESPB Group (n=25): bilateral US-guided erector spinae plane block

ACTIVE COMPARATOR

Patient in a lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed transversely to identify tip of T9 transverse process 2.5-3 cm from the midline, then it will be rotated longitudinally to get a parasagittal view, visualizing the transverse process as a hyperechoic curvilinear structure with prominent finger-like acoustic shadowing beneath , lamina , spinous process, and costochondral junction medially and laterally. The erector spinae muscles are identified superficially to the tip of the T9 transverse process.The location of the needle tip will be confirmed by hydrodissection of the erector spinae muscle from the tip of the transverse process. After negative aspiration, a total of 20 mL bupivacaine 0.25% will be injected under the fascial plane incrementally, aspirating every 5 ml and the block will be repeated on the other side

Procedure: Ultrasound guided EOI block

Interventions

Ultrasound guided EOI block PROCEDURE

Before receiving general anesthesia, patients will be randomly assigned to one of the two study groups: the EOI block group or the ESPB group. Using Ultrasound (Siemens ACUSON X300 Ultrasound System), guided blocks will be administered immediately after the induction of anesthesia and prior to surgical incision by consultant anesthesiologists who have experience in regional anesthesia and are familiar with the EOI and ESPB blocks

Also known as: Ultrasound-guided ESPB block

EOI block Group (n=25):bilateral US-guided external oblique intercostal block.; ESPB Group (n=25): bilateral US-guided erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese patients of any gender with a body mass index (BMI) of ≥ 35 kg/m2 with comorbidities or \> 40 kg/m2 and American Society of Anesthesiologists (ASA) physical status I-III and aged between 18 and 70 years scheduled for laparoscopic bariatric surgery, that is, sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgery.

You may not qualify if:

• Coagulopathy, infection at the injection site, allergy to local anesthetics, severe hepatic or renal disease, severe cardiopulmonary disease (≥ ASA IV), diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy, and inability to comprehend visual analogue scale (VAS).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Hospitals. kasralainy

Cairo, Governorate, 002, Egypt

RECRUITING

Central Study Contacts

Nagy malak

CONTACT

01552480258; nagymalak12345@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia ,SICU and pain

Model Details: Obese patients with a body mass index (BMI) of ≥ 35 kg/m2 with comorbidities or \> 40 kg/m2 and American Society of Anesthesiologists (ASA) physical status I-III and aged between 18 and 70 years scheduled for laparoscopic bariatric surgery

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 5, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)