Actively Recruiting
Evaluation and Comparison Between General Anesthesia and Two Types of Combined Spinal Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy: Multi-Center, Randomized, Controlled Trial
Led by Andrea Saporito · Updated on 2025-02-28
45
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and compare the use of general anesthesia versus two types of combined anesthesia on opioid consumption after laparoscopic hysterectomy. The study focuses on managing post-operative pain, which is important to reduce hospital stay, complications, and costs. It also examines how mixing intrathecal fentanyl with spinal anesthesia and morphine may affect pain levels and opioid needs after surgery. Participants receive one of three anesthesia approaches: general anesthesia alone, general anesthesia combined with spinal anesthesia using local anesthetic and morphine without fentanyl, or general anesthesia combined with spinal anesthesia including local anesthetic, morphine, and fentanyl. Doses of anesthetics such as propofol, rocuronium, remifentanil, bupivacaine, morphine sulfate, and fentanyl are administered according to specific protocols before and during surgery. Throughout the study, participants are monitored for opioid consumption using patient-controlled analgesia (PCA) morphine in the first 24 and 48 hours after surgery. Pain levels are assessed at multiple time points using the Visual Analogue Scale (VAS), along with evaluations of side effects like nausea, vomiting, pruritus, urinary retention, and quality of recovery using the QoR-15 score. Intraoperative hypotension and opioid use are also recorded. The study is randomized and controlled, with data collected during and after surgery to understand anesthesia effects on pain and recovery.
CONDITIONS
Brief Title
Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Female patients scheduled for laparoscopic hysterectomy (with or without adnexectomy)
- ASA physical status I to III
You will not qualify if you...
- Inability to provide consent
- Patient refusal to participate
- Contraindications to spinal anesthesia such as hemodynamic instability, infection at surgery site, neurological defects, coagulopathies, or ongoing anticoagulant therapy
- Known chronic pain syndrome
- Suspected non-compliance
- Drug or alcohol abuse
- Major oncological surgeries
- Allergy to drugs used in the study protocol
- Previous chronic use of analgesics
- History of opioid abuse
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and up to 48 hours postoperatively
Participants undergo laparoscopic hysterectomy under one of three anesthesia types: general anesthesia alone, or general anesthesia combined with spinal anesthesia containing local anesthetic and morphine, with or without fentanyl. This phase involves active management of anesthesia and postoperative pain control.
1 surgery day visit and assessments at 4, 12, 24, and 48 hours postoperatively
Trial Site Locations
Total: 2 locations
1
Ente Ospedaliero Cantonale ORBV
Bellinzona, Switzerland, Switzerland, 6500
Actively Recruiting
2
Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland, Switzerland, 6500
Not Yet Recruiting
Research Team
R
Roberto Dossi, Anesth
A
Andrea Saporito, Anesth
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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