RecruitingNot ApplicableNCT06811493

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

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


Sponsor

Kasr El Aini Hospital

Enrollment

60 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • 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

Exclusion Criteria7

  • 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.

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Interventions

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

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)


Locations(1)

Cairo University

Cairo, Egypt

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NCT06811493