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

Andrea Saporito45 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Laparoscopic Hysterectomy Gynecology

Interventions

General Anesthesia (control group)PROCEDURE

Only General Anestesia

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

General anesthesia + spinal anesthesia with local anesthetic and morfine

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

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Ente Ospedaliero Cantonale ORBV

Bellinzona, Switzerland, Switzerland

RECRUITING

Ente Ospedaliero Cantonale, Ospedale Regionale di Bellinzona e Valli

Bellinzona, Switzerland, Switzerland

NOT_YET_RECRUITING

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)

Time frame: during surgery

intraoperative opioids consumption

Time frame: during surgery

postoperative pain scores (VAS) - Visual Analogue Scale - at 4, 12, 24 and 48 hours (from 0 to 10)

Time frame: 48 hours

postoperative pruritus (rating 1-10)

Time frame: 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

Time frame: 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.

Time frame: 48 hours

Quality of Recovery (QoR-15 Score) (0 to 150)

Time frame: 48 hours

Central Contacts

Roberto Dossi, Anesth

CONTACT

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

Andrea Saporito, Anesth

CONTACT

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

Data from ClinicalTrials.gov

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