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

Andrea Saporito

Status: Enrolling

Conditions: Laparoscopic Hysterectomy; Gynecology

Treatments: Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl); Procedure: General Anesthesia (control group); Procedure: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl)

Study type: Interventional

Funder types: Other

Identifiers

NCT06642649

LpsSa

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

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

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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

study intervention NO spinal

Active Comparator group

Description:

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.

Treatment:

Procedure: General Anesthesia (control group)