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

NCT06377605 | Completed

• 1 other identifier: MD-15-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

super obese; ESPB; bariatric

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  (morphine equivalent dose) in both groups in 24hr postoperative (including Intraoperative fentanyl , and postoperative nalluphine).

  24 hours

Secondary Outcomes (1)

• VAS score during first 24 hour postoperative

  24 hours

Study Arms (2)

Erector Spinae block .

ACTIVE COMPARATOR

the block will be performed preoperatively with 1mg midazolam administration intravenous , and 5 cm lidocaine 1% infiltration at each side prior to the block . the patient will be placed in the lateral or sitting position . 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 , the distribution will be better.

Procedure: ESPB; Drug: midazolam and lidocaine

local anaesthetic infiltration

ACTIVE COMPARATOR

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

Procedure: local anaesthetic infiltration; Drug: Bupivacain

Interventions

ESPB PROCEDURE

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 ,

Erector Spinae block .

local anaesthetic infiltration PROCEDURE

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

local anaesthetic infiltration

midazolam and lidocaine DRUG

midazolam administration intravenous , and 5 cm lidocaine 1% infiltration

Erector Spinae block .

Bupivacain DRUG

bupivacaine infiltration

local anaesthetic infiltration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age \>18 \<60
• Super Obese patients ; Body mass index(BMI) \> 50 kg/m2
• Both sexes
• American Society of Anesthesiologists(ASA) physical status classes II and 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.
• Cases converted to open surgery will also be excluded from the study

Sponsors & Collaborators

• Amany Ahmed Eissa: lead

Study Sites (1)

Kasr Al Ainy Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Midazolam; Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of anesthesia& ICU

Model Details: randomized controlled trial- single blinded

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: March 10, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)