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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417179
• Other study ID #: MD-250-2020
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: February 20, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Erector Spinae Block

Intervention

Procedure:
• transversus abdominis block
transversus abdominis block
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	feasibility of block	Time taken to perform a successful block	preoperative
Other	ambulation	Time to ambulate in both groups	24 hour
Other	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
Other	pulmonary complications	Incidence of postoperative pulmonary complication ( chest x-ray at 12, 24 hr postoperative )	12,24 hours postoperative
Primary	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	failure rate	Failure rate in both groups	first hour postoperatively