Clinical trial NCT06642649: Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Hysterectomy
Gynecology
Keywords: laparoscopic hysterectomy
spinal anesthesia
general anesthesia
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, prospective, multi-center
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: PCA morphine consumption in the first 24 and 48 postoperative hours
timeFrame: 48 hours
Secondary outcomes:
measure: Number of patients with intraoperative hypotension (MAP e amine)
timeFrame: during surgery
measure: intraoperative opioids consumption
timeFrame: during surgery
measure: postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)
timeFrame: 48 hours
measure: postoperative pruritus (rating 1-10)
timeFrame: 48 hours
measure: Number of patientes with postoperative nausea and vomiting
timeFrame: 48 hours
measure: Number of patients with urinary retention
timeFrame: 48 hours
measure: Quality of Recovery (QoR-15 Score) (0 to 150)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale ORBV
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Andrea Saporito, Anesth
role: STUDY_CHAIR
References: