Skip to content
lsd.com
CompletedPhase 4

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

NCT04260659 · Medical University of Warsaw

Closed to entry
Status
Not accepting participants
Phase 4
Phase
59
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Total postoperative oxycodone consumption

    Measured over Day "0"

  • Postoperative pain score in NRS scale

    Measured over Day "0", assessed 1 hour after operation

  • Postoperative pain score in NRS scale

    Measured over Day "0", assessed 6 hours after operation

  • Postoperative pain score in NRS scale

    Measured over Day "0", assessed 12 hours after operation

  • Postoperative pain score in NRS scale

    Measured over Day "1" assessed 24 hours after operation

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Sleeve gastrectomy in patients with BMI \> 40 or \>35 with comorbidities * Written informed consent Exclusion Criteria: * Patient's refusal * Known allergies to study medication * Inability to comprehend or participate In pain scoring scale * Inability to use intravenous patient controlled analgesia * Changes of operation extent during procedure * Revisional operations

Where

1 study site

FacilityCityRegionCountry
Szpital Kliniczny Dzieciatka JezusWarsaw—Poland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04260659 on ClinicalTrials.gov →

Last updated in the registry 2023-03-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance