Efficacy of Liposomal Bupivacaine for Pain Control After Percutaneous Nephrostolithotomy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Scores from the Visual Analog Scale for pain 24 hours post-procedurally in the liposomal bupivacaine group and the bupivacaine group
研究概览
简要总结
Percutaneous nephrostolithotomy (PCNL) is a common endoscopic procedure performed for upper urinary tract calculus disease. Despite being minimally invasive, it is associated with significant postoperative pain, often necessitating inpatient hospitalization and narcotic pain medications. Additionally, one of a number of catheters is often left protruding from the access tract for a period of time following the procedure, adding to patient discomfort. Attempts have been made to study peri-tubular or access tract analgesic installation, which have shown promise.1-2 However, no studies, to our knowledge, have examined the use of liposomal bupivacaine preparations in this regard. In this study we hope to prospectively analyze the use of liposomal bupivacaine injected to the access tract site at the time of PCNL and determine its effects on postoperative narcotic requirement and pain scores.
Patients presenting for PCNL will be randomized to either the liposomal bupivacaine or usual care, which involves no injection of local anesthesia. Patients will then be followed during their inpatient stay. Total narcotic requirement (in milligrams) and pain scores (using Wong-Baker FACES rating scale) will be compared.3 Typical postoperative care and discharge criteria will not change during the course of this study.
详细描述
Subjects will be randomly assigned by a 1:1:1 ratio to one of the following groups:
- Saline (control arm)
- Liposomal bupivicaine (long-acting local anesthetic)
- Bupivacaine (local anesthetic)
The Biostatistics Unit will develop a randomization procedure using a permuted block design. Randomization will be stratified by site (LIJ or NSUH). The randomization process will occur in REDCap using the Randomization Module. Details of the procedure, including required record keeping, will be further developed upon approval of this protocol.
Patients undergoing PCNL will need no alterations of procedure in regards to positioning, obtaining access, or removal of calculi. Efforts will be made to remove the calculus with use of one access tract only; however, if the surgeon performing the procedures deems that additional access tracts are needed they can be obtained. Similarly, efforts will be taken to include a single nephrostomy tube without the need for a ureteral stent. However, if the attending surgeon deems either of these factors need to be altered, he may do so at his discretion. The use of multiple access tracts, multiple nephrostomy tubes, or a ureteral stent will then disqualify the patient from the trial and they shall then be withdrawn from the study. Because of the nature of the procedure, it is difficult to predict with certainty if patients will need any of these alterations and thus these decisions may need to be made intraoperatively.
If the patient still meets inclusion criteria, 20 mL of agent will be infiltrated subcutaneously depending on what arm the patient was randomized to. 10 mL will be place at the lateral edge of the tract while 10 mL will be placed at the medial edge. The patient will be awakened without any other changes to standard PCNL protocol. All PCNL procedures will be performed in the aforementioned manner by one of three fellowship trained endourologists with high-volume stone practices (David Hoenig, Zeph Okeke, and Arthur Smith).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years old
- •Patients with calculus disease that can be treated with PCNL
排除标准
- •Patients <18 years old.
- •Patients who are not able to give consent for study
- •Patients with active urinary tract infection
- •Pregnant women
- •Patients with hepatic insufficiency
- •Patients with more than 2 access tracts created
- •Allergies to bupivacaine or liposomal bupivacaine
- •Patients with chronic pain syndromes as determined by using >30mg oral morphine equivalents per day
- •Patients who are neurologically impaired and may have altered pain sensation due to previous diseases (e.g. paraplegics, quadriplegics, systemic neurological condition, etc.)
- •Patients who are undergoing staged procedures during that same hospital stay
- •Patients who are placed on patient controlled analgesia or patient controlled epidural analgesia
- •Patients who remain intubated after surgery
- •Patients who will have ureteral stents
- •Patients who do not require care in the intensive care unit
- •Patients who are mentally impaired.
- •Patients who are criminal prisoners.
研究组 & 干预措施
bupivicaine
干预措施: Bupivacaine (Drug)
Liposomal bupivicaine
干预措施: liposomal bupivicaine (Drug)
saline
干预措施: Saline Solution (Drug)
结局指标
主要结局
Scores from the Visual Analog Scale for pain 24 hours post-procedurally in the liposomal bupivacaine group and the bupivacaine group
时间窗: 24 hours
Scores from the Visual Analog Scale for pain 24 hours post-procedurally in the liposomal bupivacaine group and the bupivacaine group
次要结局
- narcotic usage(pain scores at 6, 12, 24, and 48 hours)
研究者
David Hoenig
Principal Investigator
Northwell Health