Does Adding Patient-controlled Sedation With Propofol During Repair of Obstetric Perineal Lacerations Grade I and II Improve Patient Experiences - a Randomized Control Trial
试验速览
- 阶段
- 4 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
The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups. A total of 80 women who undergoes examination and repair of obstetric perineal lacerations (grade I and II) are randomized into two arms (1:1); analgesia with pudendal nerve block (PNB) with ropivacaine (clinical routine, control group), or analgesia with PNB in combination with patient-controlled sedation with propofol (PCS, PCS group). The hypothesis is that PNB in combination with PCS improves patient experienced pain/discomfort during the examination and repair of the perineal laceration. The primary endpoint is patient experienced pain/discomfort. Secondary endpoints are time of repairing the perineal laceration, ability to have skin-to-skin contact with the baby during perineal repair, time until micturition after the perineal repair, procedure feasibility, amount of drugs used during perineal repair, and use of pain relief 24h postpartum. The study is planned to start during the second half of 2023 and end during the first half of 2024.
详细描述
Study design and procedure
- Study design Clinical trial, Phase IV; therapeutic use. The study is an open prospective randomized controlled low-intervention trial with parallel groups conducted in a clinical unit (single centre). The study will be conducted at the maternity ward, Vrinnevihospital (Norrköping, Sweden), according to the Helsinki Declaration principles.
- Pre-study visit All patients are informed by about the ongoing study during their last routine visit in full term pregnancy at the out-patientclinic. No informed consent is given at this point.
- Procedure Standard care are that women with a vaginal delivery undergoes examination, and further repair of perineal laceration after giving birth. Nulliparous women who have given vaginal birth and fulfil the inclusion criteria's will be given verbal and written information about the study. The physician obtains a written informed consent from the participants. Women who fulfil the criteria's and undergoes examination and repair of grades I or II will be included in the study. It shall be noted that no study-related procedures will be done prior signed consent.
Patients not fulfilling criterions for participation are given standard of care with PNB only.
Each patient who fulfils participation in the study is allocated consecutively a sealed opaque randomization envelope containing instructions if PNB should be combined with PCS during the procedure or not. There will be two study-arms: pudendal nerve block (group PNB) (todays standard of care) and pudendal nerve block with sedation using PCS with propofol (group PCS). The research subject will be randomized 1:1 to one of the two arms.
If the research person is randomized to sedation with PCS (group PCS) the midwife or obstetrician, will give additional thorough information and instructions how to operate the PCS device before initiation of the procedure.
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 —（Adult, Older Adult）
- 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
- •The patient has after receiving verbal and written information about the study given her signed informed consent to participate
排除标准
- •Perineal laceration grade III-IV
- •BMI > 35 (during first visit at the maternity care centre)
- •Deviation from department guidlines regarding preopartive fasting
- •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
研究组 & 干预措施
Patient-controlled sedation with propofol
PCS group
干预措施: PDB + PCS (Drug)
结局指标
主要结局
Pain/discomfort (perprocedural)
时间窗: From randomization up to 2 hours. Measuring starts when the procedure with examination and repair of the laceration starts. Evaluation will be done immediately after procedure when criteria of fully recovered (OAA/S 5) is fulfilled.
Perprocedural pain/discomfort; is a composite variable consisting measurements of pain and discomfort: Pain; measured with a VAS-scale (0-100 mm, "No pain" to "Worst imaginable pain") Discomfort; measured with a VAS-scale (0-100 mm, "No discomfort" to "Worst imaginable discomfort").
次要结局
- Patient experiences(From randomization Up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5).)
- Time of repair the perineal laceration(From randomization Up to 2 hours. Time for the procedure, the time between first attempt to suture until last suture.)
- Ability to have skin-to-skin contact with baby during perineal repair(From randomization Up to 2 hours. The evaluation is made immediately after procedure completion.)
- Procedure feasibility (perprocedural)(From randomization Up to 2 hours.The evaluation is made immediately after procedure completion.)
- Amount of drugs used during perineal repair(From randomization Up to 2 hours. The evaluation is made immediately after procedure completion.)
- Time until micturition after the perineal repair(Time from randomization until 24 hours after. Evalutation time between completion of procedure until first in-ward micturition.)
- Use of pain-relieving drugs 24h postpartum(On Day 1 after randomization. Evaluation after the first 24 hours after completion of procedure.)
- Patient experience(On Day 1 after randomization. Evaluates 24 hours after completion of procedure or upon discharge from hospital. Evalutation after 24 hours.)
- Preprocedural anxiety(From randomization up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5).)
- Perprocedural anxiety(From randomization Up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5).)
研究者
Marie Blomberg
Professor in Obstetrics and Gyneacology
Linkoeping University