Comparison of the Efficacy of One Level and Tow Level of Bilateral Thoracic Erector Spinae Plane Block Combined With General Anesthesia in Laparoscopic Bariatric Surgery for Obese Patients: Randomized Controlled Trial

NCT06811493 | Completed

• 1 other identifier: MD-407-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

comparison of the feasibility and efficacy of the one-level and two-level thoracic ESP block and their effect on intraoperative and postoperative analgesia in bariatric surgeries.

Conditions

Facial Plane Blocks

Keywords

erector spinae plane block, bariatric surgery, obese patients

Outcome Measures

Primary Outcomes (1)

• • visual analog scale (VAS) scores during first 24 hour postoperative

  Pain will be classified as mild (VAS 1-3), moderate (VAS 4-6), and severe (VAS 7-10) .

  post-operative period at 1 h (hour) , 2 h, 4 h, 8h, 12h,18h and 24 h (hours).

Study Arms (2)

two levels of bilateral thoracic erector spinae plane block

ACTIVE COMPARATOR

two level of bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric Surgery for obese patients

Procedure: bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric surgery in obese patients

one level of bilateral thoracic erector spinae plane block

ACTIVE COMPARATOR

one level of bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric Surgery for obese patients

Procedure: bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric surgery in obese patients

Interventions

bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric surgery in obese patients PROCEDURE

using the in-plane approach, in caudal -to- cephalad direction, through the interfascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle. the block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (15 mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process)

one level of bilateral thoracic erector spinae plane block; two levels of bilateral thoracic erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age ranges 18 to 60 years old
• Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
• American Society of Anesthesiologists (ASA) physical status classes II to III
• Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries

You may not qualify if:

• Refusal of regional block
• Patients with neurological, psychological disorders or those lacking cooperation
• Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
• Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
• Patients with bleeding disorders defined as (INR \>1.4) and/ or (platelet count \<100,000/µL)
• Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
• Patients who are allergic to amide local anesthetics.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 24, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)