Clinical trial NCT04417179: Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery
Official title: The Feasibility and Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block In Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Block
Bariatric Surgery Candidate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

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

Primary outcomes:
measure: efficacy of block
timeFrame: first 24 hours postoperative
Secondary outcomes:
measure: failure rate
timeFrame: first hour postoperatively
Other outcomes:
measure: feasibility of block
timeFrame: preoperative
measure: ambulation
timeFrame: 24 hour
measure: arterial oxygen tension to fraction of inspired oxygen ratio
timeFrame: 12, 24 hours postoperative
measure: pulmonary complications
timeFrame: 12,24 hours postoperative
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
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.
citation: 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.
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.