NCT06642649

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Andrea Saporito · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Hysterectomy
• Gynecology

Interventions

Type	Name	Description
PROCEDURE	General Anesthesia (control group)	Only General Anestesia
PROCEDURE	General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl)	General anesthesia + spinal anesthesia with local anesthetic and morfine
PROCEDURE	General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)	General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2024-10-15
• Last updated: 2025-02-28

Locations

2 sites across 1 country: Switzerland