The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients.

NCT06377605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-21

No results posted yet for this study

Summary

The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. \[1\] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing \[2\].

Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential \[14\].

Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia \[3\].

ESPB is effective, easy to perform, and can be performed in a short time. \[4\] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery \[5\]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.

Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. \[15\] Few studies examined the use of ESPB in bariatric surgery \[3,6,7\], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient.

So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries.

Conditions

  • Erector Spinae Plane Block
  • Super Obese Patients
  • Bariatric Surgery

Interventions

PROCEDURE

ESPB

the target vertebral level ( T7 transverse process ) \[8\] in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process . The Erector Spinae muscle and transverse process will be then identified, and a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in cephalad-to-caudal 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 (30 mL into each side) \[16\] into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally (at the most lateral part of the transverse process) and since it is a fascial plane block , the greater the volume of the local anaesthetic injected ,

PROCEDURE

local anaesthetic infiltration

the participant will receive 5 ml bupivacaine infiltration to each trocar site (total of 25 ml 0.5 %) at the beginning of the operation.

DRUG

midazolam and lidocaine

midazolam administration intravenous , and 5 cm lidocaine 1% infiltration

DRUG

Bupivacain

bupivacaine infiltration

Sponsors & Collaborators

  • Amany Ahmed Eissa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-10
Primary Completion
2025-05-30
Completion
2025-06-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06377605 on ClinicalTrials.gov