Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patient Pain Levels (VAS Assessment)
研究概览
简要总结
This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.
详细描述
This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
- •Parturients in active labor requesting epidural analgesia
- •Uncomplicated pregnancy with a reassuring fetal heart tracing
- •Age greater than or equal to 18 years
排除标准
- •Contraindication to epidural anesthesia
- •Inability to read, comprehend, and sign the informed consent form
- •Fetal intrauterine growth retardation (IUGR)
- •Non-reassuring fetal heart tracing
- •Cervical dilation greater than 7cm
- •Intra-uterine fetal demise
- •History of chronic pain other than in the back
- •Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (>3 attempts, presence of CSF)
- •j. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section
研究组 & 干预措施
High Volume, Low Concentration via Epidural Needle
Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via epidural needle followed by catheter placement.
For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr.
For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.
干预措施: Epidural needle (Procedure)
High Volume, Low Concentration via Epidural Catheter
Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via the epidural catheter administration following catheter placement.
For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr.
For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.
干预措施: Catheter Administration (Procedure)
Low Volume, High Concentration via Epidural Catheter
Standard of Care Epidural Administration Epidural loading: Participants will receive 10ml of 0.125% bupivacaine with fentanyl 2mcg/ml in 5 ml increments 5 minutes apart via the epidural catheter following epidural catheter placement, per standard of care.
For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.0625% bupivacaine with 2mcg/ml fentanyl. The infusion rate will be set at 10ml/hr basal rate and 4ml every 15 minutes on demand with lockout of 26ml/hr.
For inadequate analgesia: One additional 5ml boluses of the standard 0.125% bupivacaine with 2mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.
干预措施: Standard of Care Epidural Administration (Procedure)
结局指标
主要结局
Patient Pain Levels (VAS Assessment)
时间窗: During Labor
Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms
Patient Satisfaction
时间窗: During labor
Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.
次要结局
- Analgesic level(20 minutes)
- Maternal Vital Signs(20 minutes)
- Fetal Heart Rate(20 minutes)
- Rescue Bolus(During Labor)
- Intravascular Catheter Placement(During labor)
研究者
Goran Ristev
Assistant Clinical Professor of Anesthesiology
Ohio State University