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Completed

NCT Number: NCT04417179

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Cairo, 11562, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversus abdominis block

Procedure

transversus abdominis block

erector spinae block

Procedure

Erector spinae block

Bupivacaine 0.25% Injectable Solution

Drug

Local Anesthetic used in both blocks

Siemens Acuson x300 3-5MHz Ultrasound

Device

Ultrasound used to aid in the blocks

Primary outcomes

  1. efficacy of block

    Time frame: 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 outcomes

  1. failure rate

    Time frame: first hour postoperatively

    Failure rate in both groups

Other outcomes

  1. feasibility of block

    Time frame: preoperative

    Time taken to perform a successful block

  2. ambulation

    Time frame: 24 hour

    Time to ambulate in both groups

  3. arterial oxygen tension to fraction of inspired oxygen ratio

    Time frame: 12, 24 hours postoperative

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

  4. pulmonary complications

    Time frame: 12,24 hours postoperative

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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