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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04417179
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: transversus abdominis block
  • Procedure: Erector spinae block
  • Drug: Bupivacaine 0.25% Injectable Solution
  • Device: Siemens Acuson x300 3-5MHz Ultrasound
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Feasibility and Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery
Actual Study Start Date :
Aug 20, 2020
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 20, 2022

Arms and Interventions

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

Procedure: Erector spinae block
Erector spinae 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

Outcome Measures

Primary Outcome Measures

  1. efficacy of block [first 24 hours postoperative]

    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.

Secondary Outcome Measures

  1. failure rate [first hour postoperatively]

    Failure rate in both groups

Other Outcome Measures

  1. feasibility of block [preoperative]

    Time taken to perform a successful block

  2. ambulation [24 hour]

    Time to ambulate in both groups

  3. arterial oxygen tension to fraction of inspired oxygen ratio [12, 24 hours postoperative]

    p/f ratio after first 12 , 24 hours postoperatively in both groups

  4. pulmonary complications [12,24 hours postoperative]

    Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative )

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Cairo Egypt 11562

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
mohamed abdelghany ali, Anesthesia lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT04417179
Other Study ID Numbers:
  • MD-250-2020
First Posted:
Jun 4, 2020
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bupivacaine

Study Results

No Results Posted as of Mar 18, 2022