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
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Laparoscopic Hysterectomy
- Sponsor
- Andrea Saporito
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- PCA morphine consumption in the first 24 and 48 postoperative hours
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Andrea Saporito
Head of Anesthesiology, Prof.Dr.Med.
Ente Ospedaliero Cantonale, Bellinzona
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
Outcomes
Primary Outcomes
PCA morphine consumption in the first 24 and 48 postoperative hours
Time Frame: 48 hours
Secondary Outcomes
- Number of patients with intraoperative hypotension (MAP e amine)(during surgery)
- intraoperative opioids consumption(during surgery)
- postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)(48 hours)
- postoperative pruritus (rating 1-10)(48 hours)
- Number of patients with urinary retention(48 hours)
- Number of patientes with postoperative nausea and vomiting(48 hours)
- Quality of Recovery (QoR-15 Score) (0 to 150)(48 hours)