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Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy

ConditionsLaparoscopic HysterectomyGynecology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAndrea Saporito

About this trial

The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients over 18 year of age,

ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)

Disqualifiers

patients with inability to consent,

patient refusal,

contraindication to spinal anesthesia (e.g., hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis, coagulopathies or ongoing anticoagulant therapy),

known chronic pain syndrome, known

Trial design

Design model

Parallel

Treatments tested in this trial

  • General Anesthesia (control group)

    Procedure/Surgery

    Only General Anestesia

  • General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)

    Procedure/Surgery

    General anesthesia + spinal anesthesia with local anesthetic and morfine

  • General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)

    Procedure/Surgery

    General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanylActive comparator 1 intervention
Group B: study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanylActive comparator 1 intervention
Group C: study intervention NO spinalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PCA morphine consumption in the first 24 and 48 postoperative hours

Time frame
48 hours

Secondary outcomes

1

Number of patients with intraoperative hypotension (MAP e amine)

Time frame
during surgery
2

intraoperative opioids consumption

Time frame
during surgery
3

postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)

Time frame
48 hours
4

postoperative pruritus (rating 1-10)

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andrea Saporito

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

Source ClinicalTrials.gov
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