The Role of Spinal Analgesia in Laparoscopic and Laparotomic Hysterectomy: an Observational Retrospective Study (the SPIN_GYN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- Numeric pain rating scale (NPRS)
研究概览
简要总结
Perioperative multimodal analgesia, defined by the use of various analgesic medications targeting different drug receptors, provides adequate pain relief with minimal or no opiate consumption. Therefore, it represents one of the cornerstone of Enhanced Recovery After Surgery (ERAS) protocols, as the reduction in opioid use and the associated side effects may eventually reduce length of hospital stay, increase patient satisfaction and minimise the risk of long-term opioid use.
Regional and neuraxial anesthesia techniques are key interventions to provide successful analgesia in the context of a multimodal strategy. Intrathecal morphine, for its effectiveness and potential of reducing the need of intravenous postoperative opioids, seems an attractive option in the case of hysterectomy, one of the most common major surgical procedures performed in women, associated with severe postoperative pain even when performed laparoscopically.
The aim of our observational retrospective study is therefore to compare the analgesic efficacy and the safety of morphine administered by intrathecal route versus intravenous route during the first 48 hours after performance of laparoscopic/laparotomic hysterectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021.
排除标准
- •patients with American Society of Anaesthesiologists (ASA) status > 3,
- •opioid use or history of opioid dependence,
- •chronic use of analgesic medications,
- •psychiatric disorders.
研究组 & 干预措施
Intrathecal morphine
Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective laparoscopic/laparotomic hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021, who consented to the execution of a preoperative spinal analgesia with intrathecal morphine (as part of our standard practice) and who did not present any contraindications to lumbar puncture.
干预措施: Administration of morphine by intrathecal route (Procedure)
Intravenous morphine
Adult women American Society of Anaesthesiologists (ASA) physical status <= 3, scheduled for elective laparoscopic/laparotomic hysterectomy under general anesthesia between January 1st 2019 and December 31st 2021, who did not consent to the execution of a preoperative spinal analgesia or presented contraindications to lumbar puncture (coagulopathy or incorrect discontinuation of anticoagulant drugs, increased intracranial pressure, infection at the site of injection, major spinal deformities).
干预措施: Administration of morphine by intravenous route (Procedure)
结局指标
主要结局
Numeric pain rating scale (NPRS)
时间窗: 48 hours from baseline
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Numeric pain rating scale (NPRS)
时间窗: Time 0 (= baseline, i.e. at the time of Postoperative Anesthesia Care Unit arrival)
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Numeric pain rating scale (NPRS)
时间窗: 6 hours from baseline
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Numeric pain rating scale (NPRS)
时间窗: 12 hours from baseline
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
Numeric pain rating scale (NPRS)
时间窗: 24 hours from baseline
Numeric pain rating scale (NPRS) (ranging from 0, "no pain" and 10, "the worst pain imaginable") at rest
次要结局
- Length of hospital stay(Time from dismissal from PACU to dismissal from hospital, an average of 72 hours)
- Intraoperative opioid consumption(During the surgery)
- Mobilization(After the end of surgery, in the first 48 postoperative hours)
- Postoperative opioid consumption(After the end of surgery, in the first 48 postoperative hours)
- Adverse events(After the end of surgery, in the first 48 postoperative hours)
- Constipation(After the end of surgery, in the first 48 postoperative hours)
- Rescue analgesia(After the end of surgery, in the first 48 postoperative hours)
- Length of PACU stay(Time from admission to dismissal from PACU, an average of 1 hour)