The Interest of the Nociception Index (Nociception Level Index, NOL Index) for the Evaluation of Obstetric Pain Under Epidural Analgesia: a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- NOL Index variation (Delta-NOL)
研究概览
简要总结
Pain has been defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Labour pain is the pain experienced during labour and childbirth and it's characterised by nociceptive pain accompanied by sympathetic activation.
Since more than fifty years, the development of hospital obstetric assistance for labour, allowed the implementation of the pain relief culture in the demanding parturients population.
The ideal labour analgesic technique should provide consistent pain relief at any stage of labour, have a long duration of action, while being safe both for the mother and the foetus. It should also anticipate undesirable side effects, such as motor block.
The current gold standard for obstetric analgesia is the lumbar epidural technique using the administration of local anesthetics combined with opioids. However, the best administration mode is currently under debate, the main interest being the local anesthetic sparing responsible for various maternal side effects and the quality of maternal analgesia.
Despite the intense research in the field, the evaluation of the labour pain remains difficult as performed by the midwife and the anesthesiologist based on the patient's behaviour and her subjective self-assessment.
The PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel) is a non-invasive multiparametric nociception monitoring that has proved its interest in the intraoperative evaluation of patient's physiological response to pain under general anesthesia, using the NOL index variation. Nonetheless, it has been barely investigated in patients receiving locoregional anesthesia and never in the context of obstetrical pain.
The investigators support the idea that the NOL index monitoring could allow us to assess the degree of nociceptive stimulation related to obstetric labour and its variation under epidural analgesia, as well as to compare the efficacy of sensitive block using different epidural administration modes.
The aim of this pilot study is to evaluate the NOL Index variation during labour pain management with epidural analgesia.
The investigators will focus on the evaluation of analgesia in relation with the self-reported pain intensity, and secondly, the characteristics of the sensory block, the hemodynamic variables and side effects.
详细描述
- Design:
The investigators will conduct a prospective, repeated measures, monocentric, observational pilot study.
The study will be carried out in the anesthesia department of the Saint Pierre University Hospital in collaboration with the obstetrics department.
Parturient women in labour admitted into the delivery room, during the beginning of the first stage of labour demanding for an epidural will be recruited after signed written informed consent.
The number of patients to be included has been calculated to be 55. 2. Anesthetic management:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients > 18 years old, able to self-report
- •American Society of Anesthesiologists (ASA) score I to II
- •Gestational age > 36 weeks of amenorrhea
- •Primiparous or multiparous
- •In labour
- •Request and indication for epidural analgesia
- •Height 160-175cm
- •Intensity of pain objectified by Visual Analogue Scale (VAS) > 3/10
排除标准
- •Patient refusal
- •Contraindications to epidural analgesia (allergy to local anesthetics, coagulopathy, local infections)
- •BMI > 40 kg/m2
- •Weight > 110kg
- •History of caesarean section
- •Pre-eclampsia or pregnancy-induced hypertension
- •Cardiac arrhythmias (including atrial fibrillation)
- •Treatment with β-blockers
- •Chronic opioid use
- •History of substance abuse/dependency
- •Psychiatric pathology (including depression, psychosis, etc.)
- •Total language barrier
- •Epidurals at uncomfortable times (night)
结局指标
主要结局
NOL Index variation (Delta-NOL)
时间窗: 1 hour after the epidural implementation
NOL Index variation between nociceptive (contraction) and non-nociceptive (rest) periods following the implementation of the epidural
次要结局
- Sensory block(1 hour after the epidural implementation)
- Symptomatic hypotension(1 hour after the epidural implementation)
- Need of change in pump parameters(1 hour after the epidural implementation)
- Maternal satisfaction(1 hour after the epidural implementation)
- Motor block(1 hour after the epidural implementation)
- Blood pressure(1 hour after the epidural implementation)
- Parturient's self-reported pain intensity(1 hour after the epidural implementation)
- Need for PCEA rescue bolus(1 hour after the epidural implementation)
- Heart rate(1 hour after the epidural implementation)
- Nociception level(1 hour after the epidural implementation)
- Local anesthetic total dose(1 hour after the epidural implementation)
- Opioids total dose(1 hour after the epidural implementation)
- Oxygen saturation(1 hour after the epidural implementation)
- Nausea/vomiting(1 hour after the epidural implementation)