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

NCT06642649 | Recruiting

• 1 other identifier: LpsSa
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

Laparoscopic Hysterectomy; Gynecology

Keywords

laparoscopic hysterectomy; spinal anesthesia; general anesthesia

Outcome Measures

Primary Outcomes (1)

• PCA morphine consumption in the first 24 and 48 postoperative hours

  48 hours

Secondary Outcomes (7)

• 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

  48 hours

Study Arms (3)

study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl

ACTIVE COMPARATOR

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)

study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanyl

ACTIVE COMPARATOR

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)

study intervention NO spinal

ACTIVE COMPARATOR

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)

Interventions

General Anesthesia (control group) PROCEDURE

Only General Anestesia

study intervention NO spinal

General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) PROCEDURE

General anesthesia + spinal anesthesia with local anesthetic and morfine

study intervention with spinal anesthesia composed by local anesthetic, morphine and no fentanyl

General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl) PROCEDURE

General anesthesia + spinal anesthesia with local anesthetic, morfine and fentanyl

study intervention with spinal anesthesia composed by local anesthetic, morphine and 20 mcg fentanyl

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 year of age,
• ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrea Saporito: lead

Study Sites (2)

Ente Ospedaliero Cantonale ORBV

Bellinzona, Switzerland, 6500, Switzerland

RECRUITING

Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli

Bellinzona, Switzerland, 6500, Switzerland

NOT YET RECRUITING

MeSH Terms

Interventions

Anesthesia, General; Control Groups; Anesthetics, Local; Fentanyl

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrea Saporito, Anesth

  Ente Ospedaliero Cantonale, Bellinzona

  STUDY CHAIR

Central Study Contacts

Roberto Dossi, Anesth

CONTACT

0041 (0)918119341; roberto.dossi@eoc.ch

Andrea Saporito, Anesth

CONTACT

0041 (0)918118978; andrea.saporito@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Anesthesiology, Prof.Dr.Med.

Model Details: randomized, controlled, prospective, multi-center

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 28, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)