CClinicalTrials.gg
CompletedNCT04417179Updated Mar 18, 2022

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

An interventional study of transversus abdominis block and Erector spinae block in Erector Spinae Block and Bariatric Surgery Candidate, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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 .

02

Conditions studied

  • Erector Spinae Block
  • Bariatric Surgery Candidate
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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 · Drug: Bupivacaine 0.25% Injectable Solution · Device: Siemens Acuson x300 3-5MHz Ultrasound

  • 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 · Drug: Bupivacaine 0.25% Injectable Solution · Device: Siemens Acuson x300 3-5MHz Ultrasound

Interventions

  • Proceduretransversus abdominis block

    transversus abdominis block

  • ProcedureErector spinae block

    Erector spinae block

  • DrugBupivacaine 0.25% Injectable Solution

    Local Anesthetic used in both blocks

  • DeviceSiemens Acuson x300 3-5MHz Ultrasound

    Ultrasound used to aid in the blocks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: first 24 hours postoperative

Secondary outcomes

  1. failure rate

    Failure rate in both groups

    Time frame: first hour postoperatively

Other outcomes

  1. feasibility of block

    Time taken to perform a successful block

    Time frame: preoperative

  2. ambulation

    Time to ambulate in both groups

    Time frame: 24 hour

  3. arterial oxygen tension to fraction of inspired oxygen ratio

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

    Time frame: 12, 24 hours postoperative

  4. pulmonary complications

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

    Time frame: 12,24 hours postoperative

07

Study locations

1 site
  • Faculty of Medicine
    Cairo, 11562, Egypt
08

References and documents

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. PubMed 29670771 ↗
  • 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. PubMed 23811424 ↗
  • 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. PubMed 29869078 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04417179
Lead sponsor
Cairo University
Responsible party
mohamed abdelghany ali (Anesthesia lecturer, Cairo University) — Principal investigator
First posted
Jun 4, 2020
Start date
Aug 20, 2020
Primary completion
Feb 1, 2022
Completion
Feb 20, 2022
Last update
Mar 18, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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