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

NCT04417179 | Completed DMC

• 1 other identifier: MD-250-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Erector Spinae Block; Bariatric Surgery Candidate

Outcome Measures

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.

  first 24 hours postoperative

Secondary Outcomes (1)

• failure rate

  first hour postoperatively

Other Outcomes (4)

• feasibility of block

  preoperative

• ambulation

  24 hour

• arterial oxygen tension to fraction of inspired oxygen ratio

  12, 24 hours postoperative

Study Arms (2)

TAP block group

EXPERIMENTAL

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

ESP group

EXPERIMENTAL

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

transversus abdominis block PROCEDURE

transversus abdominis block

TAP block group

Erector spinae block PROCEDURE

Erector spinae block

ESP group

Bupivacaine 0.25% Injectable Solution DRUG

Local Anesthetic used in both blocks

ESP group; TAP block group

Siemens Acuson x300 3-5MHz Ultrasound DEVICE

Ultrasound used to aid in the blocks

ESP group; TAP block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine

Cairo, 11562, Egypt

Location

Related Publications (3)

• 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.

  PMID: 29670771 BACKGROUND

• 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.

  PMID: 23811424 BACKGROUND

• 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.

  PMID: 29869078 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia lecturer

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 4, 2020
• Study Start: August 20, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 20, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

EG (1)