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

Not Applicable

Recruiting

• Conditions: Laparoscopic Hysterectomy; Gynecology

• Registration Number: NCT06642649
• Lead Sponsor: Andrea Saporito

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-15
• Study Start: 2024-11-01
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PCA morphine consumption in the first 24 and 48 postoperative hours	48 hours

Secondary Outcome Measures

Name	Time	Method
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	At the time of the visit, once the bladder catheter has been removed after the operation, the patient and the care staff will be asked if any episodes of urinary retention have occurred (in the concept of a dichotomous variable YES or NO) and if further treatment has been necessary. bladder catheterization.
Number of patientes with postoperative nausea and vomiting	48 hours	At the time of the visit, the patient will be asked if any episodes of nausea or vomiting have occurred (in the concept of a dichotomous variable YES or NO) and if these have required the administration of antiemetic drugs. The number of episodes and the number of requests for drugs in reserve for management will be reported
Quality of Recovery (QoR-15 Score) (0 to 150)	48 hours

Trial Locations

Locations (2)

Ente Ospedaliero Cantonale ORBV; 🇨🇭 Bellinzona, Switzerland

Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli; 🇨🇭 Bellinzona, Switzerland