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NCT07084753Not yet recruiting

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

Comparison of Opioid-based Anesthesia, Opioid-free Anesthesia Based on Intravenous Drugs and Opioid-free Anesthesia With Thoracic Paravertebral Block, in Patients Undergoing Laparoscopic Gastric Bypass Surgery for Obesity

Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
36 (estimated)
First submitted
23 Jun 2025
Start date
30 Jul 2025
Primary completion date
30 Sept 2025
Lead sponsor
IVO JURISIC
Diseases
Obesity
NCT number
NCT07084753

What you commit to

  • Study type: Interventional
  • Planned participants: 36
  • From 30 Jul 2025 to the primary completion date, 30 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • For patients receiving thoracic paravertebral block (TPVB):
    • \- the presence of infection at the puncture site

Other illness

  • allergies to the intended medications
  • uncontrolled psychiatric disorders
  • For the OFA group:
    • 2nd or 3rd-degree atrioventricular block
    • bradycardia with a heart rate below 50 beats per minute
    • coronary artery disease,
    • cardiomyopathy.

Other

  • patient refusal
  • intracranial pathology
  • cerebrovascular damage
  • any factors impairing effective communication
    • Additional Exclusion Criteria:

Who the study is looking for

  • -. patients with a prior history of treatment by a multidisciplinary obesity team scheduled for laparoscopic sleeve gastrectomy (LSG)
  • body mass index of 30 kg/m² or greater
  • patients classified as ASA status 2-3.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Dubrava
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.