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

NCT ID: NCT04417179

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2022-02-20

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

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 .

Conditions

Erector Spinae Block; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

transversus abdominis block

Intervention Type: PROCEDURE

transversus abdominis block

Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

Local Anesthetic used in both blocks

Siemens Acuson x300 3-5MHz Ultrasound

Intervention Type: DEVICE

Ultrasound used to aid in the blocks

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

Group Type: EXPERIMENTAL

Erector spinae block

Intervention Type: PROCEDURE

Erector spinae block

Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

Local Anesthetic used in both blocks

Siemens Acuson x300 3-5MHz Ultrasound

Intervention Type: DEVICE

Ultrasound used to aid in the blocks

Interventions

transversus abdominis block

transversus abdominis block

Intervention Type: PROCEDURE

Erector spinae block

Erector spinae block

Intervention Type: PROCEDURE

Bupivacaine 0.25% Injectable Solution

Local Anesthetic used in both blocks

Intervention Type: DRUG

Siemens Acuson x300 3-5MHz Ultrasound

Ultrasound used to aid in the blocks

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

mohamed abdelghany ali

Anesthesia lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 29670771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23811424 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29869078 (View on PubMed)

Other Identifiers

MD-250-2020

Identifier Type: -

Identifier Source: org_study_id