Continuous Erector Spinae Plane Blocks to Treat Pain Following Percutaneous Nephrolithotomy: A Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The mean of the "average" pain at rest on postoperative days 1 and 2 as measured using the numeric rating scale, collected on postoperative days 1 and 2
研究概览
简要总结
This is a randomized, triple-masked, placebo-controlled parallel-arm human subjects clinical trial investigating the addition of a continuous erector spinae plane nerve block to a single-injection erector spinae plane block to provide postoperative analgesia following percutaneous nephrolithotomy. Participants will all receive a single-injection nerve block and perineural catheter insertion. Following surgery, participants will be randomly allocated to receive either perineural local anesthetic or normal saline until the second day following surgery.
详细描述
Enrollment. Participants will be consenting adults undergoing percutaneous nephrolithotomy. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained. The study population of interest includes women and men of all races, ethnicity, sexual identity, and socioeconomic status. Of note, the investigators will be using local anesthetic, perineural catheters, and infusion pumps as approved/cleared and do not plan to research a possible change of indication or use of these medications/devices as part of this research project.
Preoperative Procedures. Following written, informed consent, the investigators will record baseline anthropometric information (age, sex, height, weight, stone size/burden, comorbidities, prior stone history, glomerular filtration rate, and current stone location and burden) that is already provided by all patients having surgery. Participants will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask and positioned sitting. Midazolam and fentanyl (IV) will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The area of insertion on the ipsilateral side as the surgery will be sterilely prepared, and a clear, sterile, fenestrated drape applied. With ultrasound guidance after subcutaneous local infiltration with lidocaine, a 17g Tuohy and 5-10 ml of saline with 1:200,000 epinephrine will be used to identify the correct plane, as defined by a hyperechoic shadow of the 8th transverse process and erector spine muscle immediately superficial. Once appropriate needle tip location is confirmed, a perineural catheter will be inserted under ultrasound guidance.
Following negative aspiration, 20 mL of 0.25% bupivacaine with 1:200,000 of epinephrine will be injected via the catheter with sonographic confirmation of local anesthetic spread. Blocks will be considered successful if, within 30 minutes, the participant experiences decreased sensation to cold temperature over the level of the ipsilateral 8th thoracic dermatome at the level of anterior axillary line. Failed blocks/catheters will be successfully replaced, or the participant withdrawn from the study.
Treatment Group Assignment. Each participant will be randomized to one of two treatment groups: bupivacaine 0.25% or normal saline ("study infusate").
Randomization will be stratified by surgeon, in block sizes of 4. The randomization list will be created by the University of California San Diego Investigational Drug Service. Investigational pharmacists will prepare all study solutions as determined by the randomization list. Bupivacaine and normal saline are indistinguishable in appearance, and therefore investigators, participants, and all clinical staff will be masked to treatment group assignment for the duration of the enrollment and data collection period. Unmasking will not occur until statistical analysis is complete (termed "triple masking").
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All individuals other than the investigational pharmacist who prepares each infusion pump reservoir will be masked to treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing unilateral percutaneous nephrolithotomy in the prone position
- •analgesic plan includes a single-injection erector spinae plane block
- •age 18 years or older
排除标准
- •morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
- •renal insufficiency (abnormal preoperative creatinine or estimated glomerular filtration rate)
- •chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
- •history of opioid abuse
- •any comorbidity which results in moderate or severe functional limitation
- •inability to communicate with the investigators or hospital staff
- •pregnancy
- •bilateral or multi-stage surgical procedures
- •incarceration
- •known allergy to any study medication
- •any contraindication to perineural catheter insertion (e.g., infection at the catheter insertion site)
研究组 & 干预措施
Active Treatment
Administration of bupivacaine 0.25% through a perineural catheter inserted into the erector spinae plane (programmed intermittent bolus of 21 mL every 4 hours and no patient-controlled bolus)
干预措施: Active bupivacaine 0.25% via an erector spinae plane perineural catheter (Drug)
Placebo
Administration of normal saline through a perineural catheter inserted into the erector spinae plane (programmed intermittent bolus of 21 mL every 4 hours and no patient-controlled bolus)
干预措施: Placebo normal saline via an erector spinae plane perineural catheter (Drug)
结局指标
主要结局
The mean of the "average" pain at rest on postoperative days 1 and 2 as measured using the numeric rating scale, collected on postoperative days 1 and 2
时间窗: From discharge from the recovery room until the data collection phone call on postoperative day 1, and for the previous 24 hours of the data collection phone call on postoperative day 2.
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. To claim that the addition of an ambulatory continuous erector spinae plane block is superior to a single-injection block alone, at least one of the two primary outcomes must be superior while the other at least non-inferior.
Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 2 (measured in oral oxycodone equivalents)
时间窗: From recovery room discharge until the data collection phone call on postoperative day 2
Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 2 (measured in oral oxycodone equivalents). To claim that the addition of an ambulatory continuous erector spinae plane block is superior to a single-injection block alone, at least one of the two primary outcomes must be superior while the other at least non-inferior.
次要结局
- "Average" pain as measured using the numeric rating scale(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- Opioid consumption(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- Surgical start as recorded using military time format(Intraoperative (Within the operating room))
- Surgical duration(Intraoperative (Within the operating room))
- Wisconsin Stone Quality of Life Questionnaire (WISQOL) scores at baseline and postoperative day 2(Measured at baseline and postoperative day 2)
- Renal access location(intraoperative)
- Brief pain Inventory, short form (interference subscale)(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- Hospitalization duration(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- "Worst" pain specifically during urination as measured using the numeric rating scale(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- "Current" pain at the time of the data collection phone call as measured using the numeric rating scale(3 time points queried on postoperative days 1-3)
- Inadvertent catheter dislodgement(From the recovery room through the data collection phone call on postoperative day 3)
- "Worst" pain as measured using the numeric rating scale(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- Incidence of readmissions due to pain(From hospital discharge through the data collection call on postoperative day 3)
- Surgical stop as recorded using military time format(Intraoperative (Within the operating room))
- Time until first opioid consumption(Queried at each data collection phone call on postoperative days 1-3)
- "Least" pain as measured using the numeric rating scale(3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3)
- Sleep disturbances due to pain(3 time points queried on postoperative days 1-3)
- Incidence of returns to the emergency department for pain(From hospital discharge through the data collection call on postoperative day 3)
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego