Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A : Experimental group with intraoperative ANI monitoring of nociception
干预措施: Arm A : intraoperative ANI monitoring of nociception (Other)
Arm B : Control group without ANI intraoperative monitoring of nociception
干预措施: Arm B : no specific monitoring of nociception (Other)
结局指标
主要结局
Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
时间窗: 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.
次要结局
- Arm A : total dose of opioids received intraoperatively(Surgery)
- Arm B : total dose of opioids received intraoperatively(Surgery)
- Arm A : Patients' pain score on the VAS immediately postoperatively(within one hour of extubation)
- Arm B : Patients' pain score on the VAS immediately postoperatively(within one hour of extubation)
- Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery(3 months after surgery)
- Arm B : Arm A : proportion of patients with a DN4 questionnaire score> 4, three months after surgery(3 months after surgery)