Patient-Controlled Sedation in Port Implantation (PACSPI-2) -a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Maximal intraprocedural pain level on numeric rating scale
研究概览
简要总结
The goal of the study is to determine if patient-controlled sedation (PCS) with propofol and alfentanil reduces patient-reported pain perception during implantation of subcutaneous venous port (SVP).
The main question it aims to answer: How much pain did you (patient) experience during SVP-implantation Several other questions will be answered regarding: patient´s perception of the procedure, complication rate, procedure data.
The study contains two groups which will be compared. Control group: will do SVP implantation under local anaesthesia Study group: will do SVP implantation under local anaesthesia and patient-controlled sedation.
The patients are asked to complete a questionnaire postoperatively which contains questions on pain perception and satisfaction.
详细描述
The study is an open multicentre randomized controlled trial with a study and a control arm in a 1:1 ratio. Patients will be randomized to either a control arm of LA for SVP-implantation or a study arm of PCS with propofol and alfentanil as adjunct to LA for SVP-implantation. The aim is to randomize 340 patients with an estimated patient recruitment over 18 months with a following 6 months of data cleaning and analysis. The trial will be performed at two centres; County Hospital Ryhov, Jönköping, Sweden and University Hospital Linköping, Sweden. SVP implantation procedure and perioperative time period is estimated to 2-4 hours. The primary endpoint is assessment of patients´ self-reported pain perception. Secondary outcomes include patient satisfaction, implantation conditions, sedation level, sedative and analgesic medication consumption, procedural time consumption as well as safety aspects, adverse events and estimation of perioperative experience. Participation in the trial ends after telephone inquiry one day postoperatively.
Control arm:
SVP-implantation in LA:
Subcutanous venous ports were introduced in 1981. A SVP is a small device around 3cm in diameter with an injectable membrane buried just under the skin. It is connected to a thin tube with its tip in a large bore vein. Access to the SVP is achieved by puncturing the skin with a needle.
Local anaesthetic causes the absence of pain sensation in the location where applied by decreasing the rate of depolarization and repolarization of excitable membranes such as nociceptors and nerves. The most commonly used solutions are from the amide group differing in pharmacokinetics. In order to reduce a burning sensation on infiltration substances can be combined with sodium bicarbonate. There will be no restrictions in the choice of LA-solution being left up to local practice at participating sites. With the beginning of the procedure LA is subcutaneously applied to patients in both groups. LA used at participating centres are Mepivacaine 10mg/ml, 20-40ml subcutaneously or Lidnocaine 10mg/ml, 20-40 ml subcutaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years with cancer in need of SVP.
排除标准
- •Inability to operate the PCS apparatus.
- •Inability to communicate in Scandinavian languages.
- •Patients who require general anaesthesia or patients eligible for LA only on anesthesiologist´s assessment (i.e. severe sleep apnea).
- •Propofol or alfentanil allergy.
- •Non-fasting according to guidelines of the Swedish Society for Anaesthesia and Intensive Care (SFAI).
- •Failure to achieve peripheral vascular access.
- •Pregnancy
- •Previous participation in study
研究组 & 干预措施
Study arm (LA+PCS)
Patients in this arm will undergo SVP insertion in local anesthesia and PCS (LA+PCS)
干预措施: Propofol + Alfentanil (Drug)
结局指标
主要结局
Maximal intraprocedural pain level on numeric rating scale
时间窗: after completion of procedure 10 minutes before discharge
NRS Participants assessment of maximal pain level experienced during the procedure using a numeric rating scale from 0-10 (0=no pain, 10=worst pain I know) on patient questionnaire.
次要结局
- number of puncture attempts(during the procedure)
- use of ultrasound(during the procedure)
- Participants overall satisfaction, Participants satisfaction with staff(after completion of procedure 10 minutes before discharge)
- Number of participants with arterial puncture, pneumothorax, bradycardia, hypoxia, airway intervention, bradypnea(during the procedure)
- Sedation score on Observers Assessment of Alertness/Sedation scale (OAA/S)(during procedure at time point T1: sterile skin prepping; T2: local anaesthetic injection; T3: tunneling procedure; T4: draping removal)
- type of catheter(during the procedure)
- amount and type of local anaesthesia(during the procedure)
- time consumption of the procedure(during the procedure)
- amount of sedative medication given(during the procedure)
- positioning of catheter tip(during the procedure)
- vessel choice(during the procedure)
- Quality of Recovery QoR-15 questionnaire(within 1 hour after completion of procedure)
- Participants evaluation of the importance of receiving sedatives during the procedure Participants evaluation of the importance of being in control of sedation administration(within 1 hour after completion of procedure)