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

The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Hysterectomy; Gynecology
• Intervention / Treatment: Procedure: General Anesthesia (control group); Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl); Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Dossi, Anesth; Phone Number: 0041 (0)918119341; Email: roberto.dossi@eoc.ch
• Study Contact Backup: Name: Andrea Saporito, Anesth; Phone Number: 0041 (0)918118978; Email: andrea.saporito@eoc.ch

Study Locations

• Switzerland
  • Bellinzona, Switzerland, 6500
    • Recruiting
    • Ente Ospedaliero Cantonale ORBV
  • Bellinzona, Switzerland, 6500
    • Not yet recruiting
    • Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli
    • Contact: Roberto Dossi, Anesth; Phone Number: 0041(0)918119341; Email: roberto.dossi@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study intervention NO spinal; Every patient will receive a general anesthesia induced with propofol (1.5-2.5 mg/kg, individually adjusted), rocuronium (0.6 mg/kg) for muscle relaxation and a continuous infusion of remifentanil (0.05-0.3 mcg/kg/min, depending on the clinical characteristics of the patient). General anesthesia was maintained with a continuous infusion of propofol (4-8 mg/kg/h), and the infusion of remifentanil which was started with the induction. Fractionated doses of rocuronium were administered based on TOF monitoring (train of four) to maintain muscle relaxation.	Procedure: General Anesthesia (control group); Only General Anestesia
Active Comparator: study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl; Every patient will receive, before induction of general anesthesia as in control group, a spinal anesthesia composed by hyperbaric bupivacaine 5 mg 0,5% and morphine sulfate 100 mcg.	Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl); General anesthesia + spinal anesthesia with local anesthetic and morfine
Active Comparator: study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanyl; every patient will receive, before induction of general anesthesia, as in the control group, a spinal anesthesia composed by hyperbaric bupivacaine 5 mg 0,5%, morphine sulfate 100 mcg and fentanyl 20 mcg.	Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl); General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PCA morphine consumption in the first 24 and 48 postoperative hours	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 patientes with postoperative nausea and vomiting	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	48 hours
Number of patients with urinary retention	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.	48 hours
Quality of Recovery (QoR-15 Score) (0 to 150)		48 hours

Collaborators and Investigators

• Sponsor: Andrea Saporito
• Investigators: Study Chair: Andrea Saporito, Anesth, Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; spinal anesthesia; laparoscopic hysterectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Fentanyl; Anesthetics, Local
• Other Study ID Numbers: LpsSa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No