Comparison of Safety and Efficacy Between Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI) for Labour Epidural Analgesia: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- To compare the incidence of motor block during labour between parturient with PIEB + PCEA and those with CEI.
研究概览
简要总结
The goal of this clinical trial is to compare safety and efficacy of programmed intermittent epidural bolus (PEIB) and continuous epidural infusion (CEI) in parturients during active phase of labour.
The main questions aimed to answer are:
- Will parturient using PIEB+PCEA has lower incidence of motor block as compared to CEI during labour?
- Will parturient using PIEB + PCEA has lower local anaesthetic consumption (in mg/hr) as compared to CEI during labour?
- Will parturient using PIEB + PCEA has shorter duration of second stage labour as compared to CEI?
- Will parturient using PIEB + PCEA has better satisfaction score when compared to CEI during labour?
Participants will be randomised into PIEB group and CEI group after informed consent taken
- All participants will be taken baseline demographic data, vital signs, Bromage score, cardiotocograph prior intervention
- Labour epidural will be inserted and started on PIEB protocol or CEI protocol based on randomisation
- Participants vital signs and Bromage score will be recorded hourly till baby delivery
- In the end of delivery, total LA consumption and duration of second stage will be recorded
- Within 24 hours, participants will be interviewed on their satisfaction score on labour epidural analgesia.
Researchers will compare PIEB and CEI to see if PIEB has better safety and efficacy as compared to CEI in labour epidural analgesia.
详细描述
Parturient attending to labour room in Hospital Universiti Sains Malaysia and requested for labour epidural analgesia will be screened and recruited into this clinical trial. Before participation, an informed consent will be taken from parturient.
PIEB + PCEA or CEI will be used on recruited participants based on the randomised group by primary investigator. Setup of epidural cocktail infusion pump either CADD-Solis ® pump or normal infusion pump, will be done by anaesthetic officer attending the patient.
For PIEB group, ropivacaine 0.05% + fentanyl 2mcg/ml in 100ml bag will be used for epidural analgesia. For CEI group, bupivacaine 0.1% + fentanyl 2mcg.ml in 50ml will be used for epidural analgesia. Both epidural cocktails are prepared by central pharmacist in sterile technique. Participants, researcher and the anaesthetist-in-charge can't be blinded from the study in view the CADD-Solis ® pump is unique with its PCEA bolus cord.
Prior procedure, participants baseline pain score, CTG, vital signs, Bromage score will be recorded prior to epidural catheter insertion. If CTG and vital signs are reassuring, then only anaesthetist-in-charge will proceed with epidural catheter insertion.
There will be assigned two groups of patients receiving different epidural regimen;
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
- Single (Outcomes Assessor)
盲法说明
Participant and clinician cant be blinded in this study in view that CADD-Solis pump used in programmed intermittent epidural bolus (PIEB) group is different from conventional infusion pump with distinct patient bolus button.
Although participant can be blinded by introducing placebo bolus in continuous epidural infusion (CEI) group, it is unethical to do so, especially when involves obstetric patient that encounter labour pain during active phase of labor.
Only assessor can be blinded by masking the labor epidural analgesia delivery pump (be it CADD-Solis pump or conventional infusion pump), thus to reduce bias in the observed outcome
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
- •age > 18 years old
- •ASA 2 & 3w
排除标准
- •patient refusal
- •significant comorbiddities, eg patient with heart disease, kidney diseae, neurological disoder
- •contraindicated to neuraxial blockade
- •allergic to local anesthetic agent or opioid
- •obstetric complications, eg pre-eclampsia, leaking liqour, suspicious CTG
- •morbid obesity, BMI > 40
- •grandmultiparous ( > 5biths at > 20 weeks gestation)
- •combined spinal epidural technique for labour epidural analgesia
- •height < 145cm
结局指标
主要结局
To compare the incidence of motor block during labour between parturient with PIEB + PCEA and those with CEI.
时间窗: 1 year
Bromage score is measured hourly after epidural insertion. If there is any time when Bromage is greater than 0, then will be considered presence of motor block.
次要结局
- To compare the duration of second stage labour between parturient with PIEB+CEA and those with CEI.(1 year)
- To compare the local anaesthetic consumption (in mg/hr) during labour between parturient with PIEB + PCEA and those with CEI(1 year)
- To compare the satisfaction score during labour between parturient with PIEB+PCEA and those with CEI(1 year)
研究者
Koeh Shao Keong
Dr
Hospital Universiti Sains Malaysia