Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery

The Feasibility and Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery

The purpose of this study to compare erector spinae block to transversus abdominis plane block in bariatric surgeries regarding analgesic efficacy and postoperative oxygenation and respiratory complications

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate; Erector Spinae Block
• Intervention / Treatment: Procedure: transversus abdominis block; Drug: Bupivacaine 0.25% Injectable Solution; Device: Siemens Acuson x300 3-5MHz Ultrasound; Procedure: Erector spinae block

Detailed Description

The erector spinae plane (ESP) block is an interfascial block proposed to provide analgesia for chronic pain and perioperative period. it can provide both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level. ESP block is effective, easy to perform, and can be performed in a short time. Therefore, bilateral ESP block may have comparable or improved analgesic effect in upper and lower abdominal surgical procedures when compared to other suitable plane blocks.

Transversus abdominis plane (TAP) block technique is to reduce postoperative pain and is a part of current analgesic regimen for many abdominal surgeries . Moreover, it was found that posterior TAP block appears to produce more prolonged analgesia than the lateral TAP block. Ultrasound guided TAP block is a feasible, minimally invasive technique . It reduces the postoperative requirement of opioid analgesics, decreases the incidence and severity of postoperative nausea and vomiting, improves patient satisfaction, and allows early readiness for discharge postoperatively.

Both blocks is effective in reducing postoperative complication and need of analgesia , To our knowledge there is no comparative study between the two blocks to this population .

the investigators aim to compare the perioperative analgesic effect between TAP block and ES block in bariatric .

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient age >18 <60
• Obese patients ; Body mass index(BMI) 40-50 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

Exclusion Criteria:

• 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 >2) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block group; the TAP block will be given by a high frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound . a blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under direct ultrasound visualization, . After confirming the correct placement of the needle and the negative aspiration probe anaesthetic substance will be injected along the subcostal line in the transversus abdominis plane 20 ml 0.25% bupivacaine(10) , and the dissection of the plane was observed. The block will be performed bilaterally.	Procedure: transversus abdominis block; transversus abdominis block; Drug: Bupivacaine 0.25% Injectable Solution; Local Anesthetic used in both blocks; Device: Siemens Acuson x300 3-5MHz Ultrasound; Ultrasound used to aid in the blocks
Experimental: ESP group; the Erector Spinae block will be given by a high-frequency linear ultrasound transducer of Siemens acuson x300 3-5MHz ultrasound .A blunted tip , 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be used under strict aseptic precautions until the tip is deep to erector spinae muscle, The block will be performed bilaterally by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the transverse processes of the lumbar vertebrae laterally	Drug: Bupivacaine 0.25% Injectable Solution; Local Anesthetic used in both blocks; Device: Siemens Acuson x300 3-5MHz Ultrasound; Ultrasound used to aid in the blocks; Procedure: Erector spinae block; Erector spinae block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of block	The analgesic efficacy of erector spinae block versus TAP block assessed by visual analogue score(range from 1 denoted the least pain to 10 as the worst pain) in 24hr in laparoscopic bariatric surgery.	first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure rate	Failure rate in both groups	first hour postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of block	Time taken to perform a successful block	preoperative
ambulation	Time to ambulate in both groups	24 hour
arterial oxygen tension to fraction of inspired oxygen ratio	p/f ratio after first 12 , 24 hours postoperatively in both groups	12, 24 hours postoperative
pulmonary complications	Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative )	12,24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.
• Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
• Mittal T, Dey A, Siddhartha R, Nali A, Sharma B, Malik V. Efficacy of ultrasound-guided transversus abdominis plane (TAP) block for postoperative analgesia in laparoscopic gastric sleeve resection: a randomized single blinded case control study. Surg Endosc. 2018 Dec;32(12):4985-4989. doi: 10.1007/s00464-018-6261-6. Epub 2018 Jun 4.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MD-250-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No