2022-502292-39-00招募中3 期
Does adding patient-controlled sedation with propofol during repair of obstetric perineal lacerations grade I and II improve patient experiences - a randomized control trial
Region Oestergoetland1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年3月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain/discomfort (perprocedural)
研究概览
简要总结
To investigate patient pain/discomfort and complications when patient-controlled sedation with propofol is added to standard routine with pudendal nerve block during repair of obstetrical perineal lacerations grade I and II.
研究设计
- 分配方式
- Randomized
- 主要目的
- Participation
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient (≥18 years)
- •Planned examination and repair of perineal laceration grades I or II
- •The patient has after receiving verbal and written information about the study given her signed informed consent to participate
排除标准
- •BMI > 35 (during first visit at the maternity care centre)
- •Preeclampsia or hypertensive disease
- •Postpartum haemorrhage > 1000 ml
- •Known/suspected allergy or contraindication to any medication within the study
- •Functional disability in both hands which affect the possibility to operate the PCS device
- •Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device
- •Perineal laceration grade III-IV
- •Deviation from department guidlines regarding preopartive fasting
结局指标
主要结局
Pain/discomfort (perprocedural)
Pain/discomfort (perprocedural)
次要结局
- Preprocedural anxiety
- Time of repair the perineal laceration
- Ability to have skin-to-skin contact with baby during perineal repair
- Time until micturition after the perineal repair
- Procedure feasibility
- Amount of drugs used during perineal repair
- Use of pain relief 24h postpartum
- Patient experience after repair of perineal laceration 4 days postpartum
- Need of pain-relieving within 24 h postpartum
- Time to mobilisation of the patient
- Time to micturition
- Perprocedural anxiety
研究者
Linda Hjertberg
Scientific
Region Oestergoetland
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Patient-controlled sedation during repair of obstetric perineal lacerationsObstetric perineal lacerationsCTIS2022-502292-39-00Region Oestergoetland80
招募中
3 期
« Effect of sedative and anxiolytic sedation on children experience after general anesthesia »
PEDIA_prem study.2022-501124-23-00Centre Hospitalier Universitaire De Montpellier1,000
已完成
不适用
Use of Subanesthetic Dose Propofol Before ExtubationNCT07276633Yuzuncu Yil University80
进行中（未招募）
1 期
Sedation during examination with bronchoscopyEUCTR2015-005274-38-SERegion Östergötland300
已完成
3 期
Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel ExplorationNCT07269808Massachusetts General Hospital100