全身麻醉下术中镇痛的特异性监测对卵巢癌手术后慢性疼痛的影响 (MONIALC)
全身麻醉下术中镇痛的特异性监测对卵巢癌手术后慢性疼痛的影响。 MONIALC 研究。
This is a single-center, randomized, phase II, non-comparative, single-blind clinical study that will determine whether morphine reduction through intraoperative monitoring by ANI (Analgesia Nociception Index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.
研究概览
地位
条件
详细说明
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
Before inclusion,all eligibility criteria will be verified, VAS pain score and VAS anxiety will be performed.
The surgical procedure for ovarian carcinoma will be performed by laparotomy and the intraoperative monitoring of nociception wil depend of the randomization arm : Intraoperative ANI monitoring of nociception (experimental arm) versus no specific monitoring of nociception (control arm). The total dose of opioids (in micrograms) received by the patients will be recorded at the end of the surgery.
VAS pain score will be performed immediately postoperatively and at three months after the intervention. A DN4 questionnaire (neuropathic pain) will be evaluated at three months after the intervention.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Bordeaux、法国、33076
- Institut Bergonié
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Woman aged 18 years and over.
- Histologically proven or strongly suspected ovarian carcinoma.
- Indication for laparotomy surgery with xyphopubic incision.
- Acceptance of epidural anesthesia.
- Pain score ≤ 3 (VAS or Numeric Verbal Scale).
- Free and informed consent.
- Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.
Exclusion Criteria:
- Heart rhythm disturbances.
- History of Cerebral Vascular Accident (CVA).
- History of epilepsy.
- Wearing a pacemaker.
- Receiving morphine treatment preoperatively.
- Medical contraindication to an epidural.
- Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient already included in the present study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A 组：术中 ANI 监测伤害感受的实验组
|
For the experimental group (arm A), the sufentanil doses are adjusted to maintain an ANI between 50 and 70. Morphine doses are adjusted from 0.05 to 0.05 µg / ml. Intraoperative data will be collected for ANI, TIVA and hemodynamics. |
|
其他：B 组：无 ANI 术中伤害感受监测的对照组
|
For the control group (arm B), adjustments to the opioid doses are made in relation to the hemodynamic reactions of the patient and the operating times. Intraoperative data will be collected for TIVA and hemodynamics. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
大体时间：3 months after surgery
|
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant. |
3 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
A 组：术中接受的阿片类药物总剂量
大体时间：外科手术
|
外科手术
|
|
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B 组：术中接受的阿片类药物总剂量
大体时间：外科手术
|
外科手术
|
|
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A 组：DN4 问卷评分> 4 的患者比例，术后三个月
大体时间：手术后3个月
|
手术后3个月
|
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B 组：A 组：DN4 问卷评分> 4 的患者比例，术后三个月
大体时间：手术后3个月
|
手术后3个月
|
|
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Arm A : Patients' pain score on the VAS immediately postoperatively
大体时间：within one hour of extubation
|
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant. |
within one hour of extubation
|
|
Arm B : Patients' pain score on the VAS immediately postoperatively
大体时间：within one hour of extubation
|
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant. |
within one hour of extubation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IB 2020-04
- 2020-A02767-32 (其他标识符：ANSM IDRCB number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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