Optimum Length of Catheter in the Epidural Space for Labor Analgesia in Non-obese Women: a Randomised Controlled Trial of 4 cm Versus 5 cm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensory block level < T10
研究概览
简要总结
Epidural analgesia was introduced to the world of obstetrics in 1909 by Walter Stoeckel. Over the following 100 years it has developed to become the gold-standard for delivery of intra-partum analgesia, with between 60 and 75% of North American parturients receiving an epidural during their labor. Effective labor analgesia has been shown to improve maternal and fetal outcomes. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space. Dislodgement or displacement of epidural catheter remains a significant cause for failure with analgesia. Novel methods of fixation may further reduce the risk of catheter migration. Another factor is the direction of travel within the epidural space, only 13% of lumbar catheters remain uncoiled after insertion of more than 4 cm into the epidural space.
Hypothesis: The investigators hypothesize that catheters inserted to 4 cm will have a lower rate of failure when compared to those inserted to 5 cm.
Objective: This study aims to evaluate the difference in quality of labor analgesia delivered by epidural catheters inserted to either 4 or 5 cm into the epidural space.
This study will be conducted as an interventional double-blinded randomised control trial to establish best practice.
详细描述
Effective labor analgesia has been shown to improve maternal and fetal outcomes. It is of paramount importance to the obstetric anesthesiologist to optimize the quality of labor analgesia and identify any factors leading to ineffective epidural analgesia. One aspect of catheter insertion that has not been fully evaluated, and with very little recent work undertaken, is the optimal length of epidural catheter to be left in the epidural space.
Previous studies have advocated, for varying reasons, different lengths of catheter to be left in the space; these range from 2cm to 8cm. Longer epidural lengths in the space can be associated with foraminal escape, leading to unilateral block, and intravascular insertion, prompting additional manipulation. Shorter lengths have previously been associated with more frequent dislodgement. The directionality of the epidural catheter once in the space has been demonstrated to correlate with misdirection.
The aim of the study would be to standardize practice in how much epidural catheter is threaded into the epidural space.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The anesthesiologist placing the epidural will know the group assignment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women aged 18 years and above.
- •In established second stage of labor.
- •3-7 cm dilation at time of insertion.
- •Women with BMI < 40 kg/m2
排除标准
- •Known contraindication to epidural insertion.
- •Inability or unwillingness to provide written consent.
- •Previous difficult epidural insertion.
- •Previous failed epidural.
- •Imminent instrumental or operative delivery.
- •Dural puncture.
- •Combined spinal epidural analgesia.
- •High BMI > 40 kg/m2
研究组 & 干预措施
4 cm epidural catheter
The epidural catheter will be thread into the epidural space at a length of 4 cm.
干预措施: Epidural catheter (Other)
5 cm epidural catheter
The epidural catheter will be thread into the epidural space at a length of 5 cm.
干预措施: Epidural catheter (Other)
结局指标
主要结局
Sensory block level < T10
时间窗: 1 hour
Sensory block level to ice will be measured 1 hour after the loading dose is administered. Yes: inadequate block No: adequate block
Adjustment of catheter length
时间窗: 24 hours
Adjustment of catheter length at any time during labour would also indicate an inadequate block.
Abandonment of epidural or substitute for alternative method of analgesia after initial failure: questionnaire
时间窗: 24 hours
The epidural analgesia will also be considered inadequate if the procedure is abandoned or another method of analgesia is used. This will be recorded by the anesthesiologist.
Block height discrepancy
时间窗: 24 hours
Unilateral block or block height discrepancy of \>3 dermatomal levels at any time prior to delivery. Yes: inadequate block No: adequate block
Re-siting of the epidural
时间窗: 24 hours
Re-siting of the epidural at any time during labour will indicate an inadequate block, for any of the following reasons: * Inadequate analgesia * Persistent unilateral block * Persistent intravascular placement * Extensive motor block * Hypotension * High block
次要结局
- Motor block using Bromage scale(24 hours)
- Incidence of catheter dislodgement(24 hours)
- Pain score >3 at any time during labour: questionnaire(24 hours)
- Number of epidural top-ups administered by the anesthesiologist(24 hours)
- Adequacy of conversion to surgical block if required for cesarean delivery: questionnaire(24 hours)
- Number of epidural top-ups administered by the nursing team(24 hours)
- Hourly sensory block height assessment(24 hours)
- Presence of paresthesia on insertion.(1 hour)
- Pain scores recorded throughout labour: questionnaire(24 hours)
- Incidence of intravascular epidural placement(24 hours)