Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIVO JURISIC

About this trial

Regional anesthesia is a technique in which a local anesthetic is injected near a nerve or spinal cord to block sensation, motor stimulation, and pain. In this study, an ultrasound-guided paravertebral block will be used, with careful consideration of all positive and negative factors and possible complications. A thoracic paravertebral block is performed by inserting a needle into the intercostal spaces on the back, approximately 4 cm lateral to the spine. Many studies support excellent pain control with this technique, during and after surgery in thoracic and abdominal surgery. Investigators aim to achieve faster patient mobility after surgery, rapid recovery of bowel function, reduced nausea and vomiting, and maximum pain control. The use of opioids, which can additionally cause respiratory suppression and drowsiness, is avoided.

At any time in case of need to switch from laparoscopic to open surgery, equally adequate anesthesia and postoperative analgesia are ensured without the need to change the approach to the same. In this study, the basic scientific assumption (hypothesis) of the researchers is that non-opioid anesthesia with thoracic paravertebral block provides adequate pain control during and long-term after the surgical procedure, without the side effects of opioid anesthesia.

The main goal of the study is to determine which type of anesthesia results in the best pain control and most significantly reduces complications of anesthesia and surgery in overweight patients who are scheduled for laparoscopic longitudinal gastrectomy and partial/total gastrectomy.

Eligibility criteria

Qualifiers

body mass index of 30 kg/m² or greater

patients classified as ASA status 2-3.

Disqualifiers

allergies to the intended medications

patient refusal

uncontrolled psychiatric disorders

intracranial pathology

Trial design

Treatments tested in this trial

  • Levobupivacaine
  • Dexamethasone contained in the solution for thoracic paravertebral block
  • Adrenaline
  • Dexmedetomidin
  • ketamine
  • Lidocain
  • Sufentanil
  • Opioid free anesthesia based on thoracic paravertebral block
  • Opioid based Anesthesia
  • Opioid free anesthesia, Opioid free anesthesia based on intravenous dexmedetomidine, ketamine and lidocainedexmedetomidine, ketamine and lidocaine
  • Ultrasound guided thoracic paravertebral block
  • Nerve stimulator for peripheral nerve blocks
  • Metoclopramide 10mg
  • Ondasetron 4mg
  • Thiethylperazine
  • Dexamethasone, 8 mg intravenously

Treatment groups

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators

IVO JURISIC

Lead sponsor

University Hospital Dubrava

Sponsor institution