Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate

• Registration Number: NCT03747406
• Lead Sponsor: Dalia Ismail

Brief Summary

assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block.

Detailed Description

Primary outcomes

• Cumulative opioid consumption during the first 24 h postoperatively. For the purpose of comparison, all opioids administered postoperatively will be converted to IV morphine equivalent doses using standard opioid dosage conversion tables.

Secondary outcome parameters

1. Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.

2. Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.

3. Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).

4. Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-17
• Study First Posted: 2018-11-20
• Study Start: 2018-12-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-10
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• • Patients from 18 to 59 years.

  • BMI > 40 kg/m2
  • Genders eligible for study: both.
  • ASA I-III.
  • No contraindications for application of regional anesthesia as Patient refusal, local anesthetic allergy, local sepsis or infection at puncture site, INR > 1.5 or < 12 hours post LMWH.

Exclusion Criteria

• • Patient refusal.

  • Extremes of age.
  • ASA IV.
  • Increased intracranial pressure.
  • Coagulopathy or thrombocytopenia less than 100000/ml.
  • Sepsis (increased risk of meningitis).
  • Infection at the puncture site.
  • Pre-existing neurologic disease.
  • History of allergy to local anesthetic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative opioid consumption during the first 24 h postoperatively	24 hours after surgery	measure total opioid dose in 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
pain assessment by Visual Analog Scale	24 hours after surgery	it is a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.If the VAS level is 5 or more this means failure of analgesio and a dose of rescue analgesia is given

Trial Locations

Locations (1)

Faculty of Medicine - Cairo University; 🇪🇬 Cairo, Egypt