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Clinical Trials/NCT03747406
NCT03747406
Completed
Not Applicable

Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.

Dalia Ismail1 site in 1 country66 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bariatric Surgery Candidate
Sponsor
Dalia Ismail
Enrollment
66
Locations
1
Primary Endpoint
Cumulative opioid consumption during the first 24 h postoperatively
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
July 10, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dalia Ismail
Responsible Party
Sponsor Investigator
Principal Investigator

Dalia Ismail

Lecturer of Anaesthesia- Cairo University

Cairo University

Eligibility Criteria

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.
  • 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.

Outcomes

Primary Outcomes

Cumulative opioid consumption during the first 24 h postoperatively

Time Frame: 24 hours after surgery

measure total opioid dose in 24 hours after surgery

Secondary Outcomes

  • pain assessment by Visual Analog Scale(24 hours after surgery)

Study Sites (1)

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