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

Last updated: February 26, 2025
Sponsor: Andrea Saporito
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Treatment

General Anesthesia + Spinal anesthesia combined

General Anesthesia (control group)

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

Clinical Study ID

NCT06642649
LpsSa
  • Ages > 18
  • Female

Study Summary

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

Inclusion

Inclusion Criteria:

  • patients over 18 year of age,

  • ASA physical status I to III scheduled for laparoscopic hysterectomy (with orwithout adnexectomy)

Exclusion

Exclusion Criteria:

  • patients with inability to consent,

  • patient refusal,

  • contraindication to spinal anesthesia (e.g., hemodynamic instability, infection atthe surgery site, and neurologic defects such as transverse myelitis, coagulopathiesor 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

Study Design

Total Participants: 45
Treatment Group(s): 4
Primary Treatment: General Anesthesia + Spinal anesthesia combined
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Ente Ospedaliero Cantonale ORBV

    Bellinzona, 6500
    Switzerland

    Active - Recruiting

  • Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli

    Bellinzona, 6500
    Switzerland

    Site Not Available

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