Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- VAS anxiety score
研究概览
简要总结
This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery:
Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.
详细描述
In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block:
Group 1: neuroleptanalgesia Group 2: hypnoanalgesia Primary objective The main objective of the study is to compare changes in preoperative anxiety between the two groups, between two measurements taken preoperatively (before anxiety management) and at the end of surgery. This level will be evaluated using a VAS rated from 0 to 10.
Secondary objectives
Comparing groups:
- Intraoperative pain
- Total duration of surgical procedure, ICU stay and hospitalization
- Amount of additional sedative treatment administered during surgery
- Post-operative pain
- Patient satisfaction
- Intraoperative and immediate postoperative adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80,
- •Patient who has read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes).
- •Patient applying for outpatient hand surgery under LRA, such as upper limb trunk blocks (flexor teno synovectomy or endoscopic carpal tunnel surgery).
- •Patient requiring sedation associated with locoregional anaesthesia
排除标准
- •Contraindication to locoregional anaesthesia or to one of the sedatives used in the protocol
- •Pregnant or breastfeeding patient or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be women after menarche and until they become post-menopausal, unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal state is defined as the absence of menstruation for 12 months without any other medical cause.
- •Patient under court protection, guardianship or curatorship
- •Patient not affiliated to the French social security system
- •Patients unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patients, etc.
研究组 & 干预措施
Usual neuroleptanalgesic treatment
Usual neuroleptanalgesic treatment Hypnovel (1 mg if weight < 60 kg, 1.5 mg if weight between 60 and 80 kg, 2 mg if weight > 80 kg)
干预措施: Neuroleptanalgesic treatment (Drug)
Hypnoanalgesia
Patients in this group will begin their hypnoanalgesia session with a nurse trained in hypnotherapy. Various methods commonly used in hypnosis (VAKOG, dissociation, diversion, metaphors, etc.) will be selected based on the patient, their personality, their expectations, and their degree of suggestibility.
干预措施: Hypnoanalgesia (Other)
结局指标
主要结局
VAS anxiety score
时间窗: Day 2
Changes in VAS anxiety score between preoperative and intraoperative assessment. Anxiety will be assessed on a visual analog scale measuring 10 cm (with 0 = no stress - 10 = major stress) and by administering the APAIS scale.
次要结局
- Treatment Safety(Day 2)
- Pain intensity assessment(Day 2)
- Overall patient satisfaction(Day 2)