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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- PCA morphine consumption in the first 24 and 48 postoperative hours
研究概览
简要总结
The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients over 18 year of age,
- •ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and no fentanyl) (Procedure)
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.
干预措施: General Anesthesia + Spinal anesthesia combined (local anesthetic, morfine and 20 mcg fentanyl) (Procedure)
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.
干预措施: General Anesthesia (control group) (Procedure)
结局指标
主要结局
PCA morphine consumption in the first 24 and 48 postoperative hours
时间窗: 48 hours
次要结局
- 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 patients with urinary retention(48 hours)
- Number of patientes with postoperative nausea and vomiting(48 hours)
- Quality of Recovery (QoR-15 Score) (0 to 150)(48 hours)
研究者
Andrea Saporito
Head of Anesthesiology, Prof.Dr.Med.
Ente Ospedaliero Cantonale, Bellinzona