Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Composite outcome: Failure of Labour epidural catheter or PIEB protocol
研究概览
简要总结
This study will randomise pregnant women to labour epidural at a higher versus a lower lumbar level. Outcomes relating to success or failure of the epidural catheter at this level will be assessed.
详细描述
Epidural analgesia is widely used in different types of surgeries and procedures. Pregnant women in labour compromise the single largest group benefiting from epidural analgesia. During first stage of labour (dilatation of the cervix), an epidural should cover the sensory dermatomes from T10 to L1 to achieve a good pain relief. In the second stage of labour (descent of the baby through the cervical canal), pain is mediated via S2-S4 nerve roots. Accordingly, labour epidurals are commonly placed at the lower lumbar (L3-L4) interspace.1 A study was conducted by Moore et al., comparing high vs low lumbar epidural, showed that lower epidurals provide superior perineal analgesia, when used with a patient-controlled epidural analgesia (PCEA) infusion with continuous epidural infusion (CEI), but provided less pain relief early in labour. Another study, a metanalysis showed that another mode of delivery of the local anaesthetics is more effective; which is the Programmed Intermittent Epidural Boluses (PIEB) with PCEA. The incidence of breakthrough pain, the rates of local anaesthetic usage were significantly reduced, the labour duration was statistically shorter, and the maternal satisfaction score was significantly improved in the PIEB + PCEA group compared with that in the CEI + PCEA group.
This is a prospective randomised study where women will be randomised to a high or low epidural catheter to determine which is superior for maternal analgesia efficacy and satisfaction.
Randomised to intervention 'high epidural' or 'low epidural' groups. Within these groups there are two subgroups based on the specific lumbar vertebral level; high epidural (L 1,2 or L 2,3 levels) and low epidural (L 3,4 or L 4,5 levels).
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
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing induction of labour who plan to have epidural analgesia
排除标准
- •Known contraindication to epidural analgesia. Neurological illness Multiple gestation Fetal abnormalities In distress or requiring immediate epidural catheter placement
研究组 & 干预措施
Epidural analgesia performed at a higher lumbar epidural level
Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter at a higher lumbar epidural level sited at L1,L2 or L2,L3
干预措施: Epidural Analgesia (Procedure)
Epidural analgesia performed at a lower lumbar epidural level
Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter sited at lower epidural level (L3,L4 or L4,L5)
干预措施: Epidural Analgesia (Procedure)
结局指标
主要结局
Composite outcome: Failure of Labour epidural catheter or PIEB protocol
时间窗: During labour
Composite outcome of 1/Failure to insert labour epidural at the assigned level OR 2/ Labour epidural catheter requires resiting OR 3/ Healthcare worker top up due to pain OR 4/ Failure of epidural conversion to epidural anaesthesia if caesarean section required
次要结局
- Pain score(60 minutes post delivery and at postnatal follow up.)
- Dermatomal sensory level assessed using cold sensation(60 minutes after insertion of the epidural catheter)
- Bromage score(60 minutes after insertion of labour epidural catheter)
- Patient Satisfaction(At follow up visit within 24 hours)
- Depth of the epidural space(At time of insertion)
- Difficulty of epidural insertion(At time of epidural insertion)
研究者
Tom Drew
Principal Investigator and Consultant Anaesthesiologist
The Rotunda Hospital
