Multimodal Post-Cesarean Analgesia With Spinal Morphine and Continuous Wound Infiltration of Ropivacaine Using the OnQ® Elastomeric Pump: A Dose-Ranging Study Using a High-Volume, Low-Dose Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline
研究概览
简要总结
The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system.
详细描述
The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system. As a double-blinded, randomized, placebo controlled study, women undergoing first, second or third cesarean section will be randomly assigned to one of 3 different groups. Group 1 will receive saline, group 2 will be given ropivacaine 0.1%, group 3 will be given ropivacaine 0.2%, all at a rate of 8ml/hr via the OnQ® pump system. Each group will also receive an 8mL bolus of the previously assigned infusate. The investigator will assess pain at rest and with movement at different time periods during the recovery process through 3 months post operatively. The investigator will also assess if the use of this system decreases the need for other pain medications and reduces the potential side-effects of pain treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections
- •Patients who are American Society of Anesthesiology (ASA) Class I-III
- •Patients are at least 34 weeks pregnant
- •Patients to receive spinal anesthesia for their procedure
- •Patients who are 18 years of age or older
- •Patient willing and able to provide written informed consent
排除标准
- •Patients with 3 or more prior Cesarean sections
- •Patients undergoing emergent cesarean section with or without general anesthesia
- •Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics
- •Patients who will not receive spinal anesthesia
- •Patients who are less than 34 weeks pregnant
- •Patients with significant maternal cardiac, liver or renal disease
- •Patients with maternal history of narcotic abuse or dependency
- •Patient with pre-operative fever (>100.4 degrees F)
- •Patients less than 18 years old
研究组 & 干预措施
Ropivacaine 0.1%
Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
干预措施: Ropivacaine 0.1% (Drug)
Ropivacaine 0.1%
Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
干预措施: On-Q ® elastomeric pump (Device)
Ropivacaine 0.2%
Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
干预措施: Ropivacaine 0.2% (Drug)
Ropivacaine 0.2%
Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.
干预措施: On-Q ® elastomeric pump (Device)
Normal Saline
Subjects undergoing their first, second or third cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
干预措施: Normal saline (Drug)
Normal Saline
Subjects undergoing their first, second or third cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.
干预措施: On-Q ® elastomeric pump (Device)
结局指标
主要结局
Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline
时间窗: 6 weeks, 3 months
Post-operative pain will be measured using a numerical pain scale (NPS). Subjects will be asked to indicate the level of pain with 0 being no pain and 10 being the worst imaginable pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain at the week 6 and 3 month time points through a telephone call.
Change in McGill Pain Questionnaire Score From Baseline
时间窗: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention
Pain with movement will be assessed using the self-report mini-McGill pain questionnaire, consisting of the first 15 questions of the McGill questionnaire, scores 0-3 points for each. It can theoretically range from 0 to 45, with 45 correlating with worse pain.
Change in Pain Scores at Rest From Baseline
时间窗: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baseline
The intensity of pain at rest will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain.
Change in Pain Scores During Cough From Baseline
时间窗: 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline
The intensity of pain during cough will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain.
Change in Pain Scores During 20°Straight Leg Raise
时间窗: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baseline
The intensity of pain during 20° straight leg raise will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Higher scores indicate higher intensities of pain.
Change in Intensity of Pain: VAPS From Baseline
时间窗: 24 hours post-intervention, 48 hrs, and 72hr post-intervention.
Incisional pain will be measured using a visual analogue pain scale (VAPS). Subjects will be instructed to indicate the intensity of the pain by marking on a 100-mm vertical lines with terms describing the extremes of pain intensity. The lines are anchored with "no pain" at the bottom and "worst imaginable pain" at the top. Pain scores range from 0-100, so the change in pain score (post- minus pre-) can theoretically range from -100 to 100. A negative score indicates an improvement in pain. Higher scores indicate higher intensities of pain. Participants will report intensity of pain 2hrs post intervention, 6hr, 12hr, 24hr, 48hr, and 72hr post-intervention.
次要结局
- Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention(24 hours, 48 hours, 72 hours post intervention)
- Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention(6 weeks postintervention, 3 months postintervention)
- Patient Satisfaction at 72 Hours Post Intervention(72 hours post-operatively)
- Dosing Amount of Non-steroidal Anti-inflammatory Drugs(24 post-operatively, 72 hours post-operatively)
- Amount of Opioid Use(24 post-operatively, 72 hours post-operatively)
- Change in Time From Baseline to First Dose of Rescue Medications(Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively)
- Breastfeeding Success(In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively)
- Cost Analysis(At the time of hospital discharge (average of 3 days))
研究者
James Dolak
Assistant Professor
Emory University