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Recruiting NCT06642649

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

No phase Interventional Laparoscopic Hysterectomy Gynecology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: General Anesthesia (control group), General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl), General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl).
Who it may be relevant to
Registry conditions: Laparoscopic Hysterectomy, Gynecology. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia (general and Spinal Anesthesia) for Opioid Consumption in Laparoscopic Hysterectomy: a Multi-Center, Randomized, Prospective, Controlled Trial

Overview

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

Detailed description

Managing post-operative pain is essential to reduce length of stay, complications, mortality, healthcare costs and the risk of readmission to hospital. At the same time, pain treatment, especially with opiod drugs, could cause side effects and worsen the quality of post-operative hospitalization. Furthermore, intrathecal fentanyl may cause an acute tolerance to opioids, and may worsen postoperative analgesia. In literature, some studies underline how the use of regional anesthesia represents an effective solution in pain control. The goal of this study would be to determine whether post-operative analgesic needs and pain levels are increased by mixing intrathecal fentanyl with spinal anesthesia and intrathecal morphine.

Interventions

  • Procedure General Anesthesia (control group)
    Only General Anestesia
  • Procedure General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)
    General anesthesia + spinal anesthesia with local anesthetic and morfine
  • Procedure General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)
    General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl

Primary outcome measures

  • PCA morphine consumption in the first 24 and 48 postoperative hours [Time frame: 48 hours]
Secondary outcome measures (7)
  • Number of patients with intraoperative hypotension (MAP e amine) [Time frame: during surgery]
  • intraoperative opioids consumption [Time frame: during surgery]
  • postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10) [Time frame: 48 hours]
  • postoperative pruritus (rating 1-10) [Time frame: 48 hours]
  • Number of patientes with postoperative nausea and vomiting [Time frame: 48 hours]
  • Number of patients with urinary retention [Time frame: 48 hours]
  • Quality of Recovery (QoR-15 Score) (0 to 150) [Time frame: 48 hours]

Eligibility criteria

Inclusion criteria

  • patients over 18 year of age,
  • ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)

Exclusion criteria

  • 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
  • suspected non- compliance,
  • drug, or alcohol abuse ,
  • major oncological surgeries,
  • allergy to drugs used in the protocol,
  • previous chronic use of analgesics
  • history of opioid abuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 2 centers
  • Ente Ospedaliero Cantonale ORBV — Bellinzona
  • Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli — Bellinzona

Identifiers

NCT: NCT06642649 · LpsSa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗