Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement
2018年6月5日 更新者：charbel salamon、Atlantic Health System
Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial
Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups.
One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution.
The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.
研究概览
地位
完全的
条件
详细说明
This is a prospective, comparative, randomized study.
Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups.
The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution.
The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.
The postoperative pain will be compared between groups using a visual analog scale.
The quality of recovery will be compared between the groups using the quality of recovery short form.
Postoperative opioid consumption will be compared between the two groups.
研究类型
介入性
注册 (实际的)
57
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Jersey
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Morristown、New Jersey、美国、07960
- Morrristown Medical Center
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Summit、New Jersey、美国、07901
- Overlool Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- ASA physical status I-III
- Age >18 years
- Not Pregnant
- Able to give informed consent
- Electively chose surgical management of SUI with a suburethral sling
Exclusion Criteria:
- Pregnant or nursing
- Allergy to amide anesthetics
- History of drug or alcohol abuse
- Severe cardiovascular, hepatic, renal disease or neurological impairment,
- Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
- Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
- Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine,
- Administration of an investigational drug within 30 days before this study
- Chronic pain syndromes
- Daily NSAID or opioid use
- Patients undergoing concomitant procedures
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Liposomal Bupivacaine
20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
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20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars
其他名称：
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
其他名称：
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有源比较器：Bupivacaine Hydrochloride and Lidocaine
Bupivacaine Hydrochloride (HCL) and Lidocaine.
Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
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A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
其他名称：
Bupivacaine Hydrochloride (HCL) and Lidocaine.
Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Day 1 Pain
大体时间：Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm.
This will be recorded by the patient prior to going to bed.
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Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Second Stage PACU Postoperative Pain
大体时间：The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU.
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The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.
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Postoperative Pain Upon Discharge
大体时间：The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital.
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The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.
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Postoperative Pain Four Hours After Discharge
大体时间：Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced.
This will be recorded 4 hours after being discharged from the hospital.
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Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Night of Surgery Postoperative Pain
大体时间：Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery.
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Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Postoperative Days 2 through 7 Pain
大体时间：Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7.
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Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Preoperative Quality of Recovery
大体时间：The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
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Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.
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The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
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Postoperative Days 1, 7 and 14 Quality of Recovery
大体时间：The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.
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The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Postoperative Narcotic Consumption
大体时间：The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed.
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The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Charbel Salamon, MD、Atlantic Health System
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年4月1日
初级完成 (实际的)
2018年5月1日
研究完成 (实际的)
2018年5月1日
研究注册日期
首次提交
2016年6月27日
首先提交符合 QC 标准的
2016年8月17日
首次发布 (估计)
2016年8月23日
研究记录更新
最后更新发布 (实际的)
2018年6月6日
上次提交的符合 QC 标准的更新
2018年6月5日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.