Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Average Pain Queried on First Postoperative Day
研究概览
简要总结
This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to automated boluses with PCA for continuous popliteal sciatic nerve blocks. The goal will be to determine the relationship between method of local anesthetic administration (continuous with PCA initiated at discharge vs. intermittent dosing with PCA with a 5-hour delay) for continuous peripheral nerve block and the resulting pain control and duration of analgesia.
详细描述
Specific Aim: To determine the relationship between method of local anesthetic administration (continuous with PCA vs. intermittent dosing with PCA) for continuous peripheral nerve block and the resulting pain control.
Hypothesis: The investigators hypothesize that, compared with a traditional fixed, continuous basal infusion initiated prior to discharge, perineural local anesthetic administered with variable automated boluses at a lower dose and a 5-hour delay following discharge will (1) provide at least noninferior analgesia during the period that both techniques are functioning; and, (2) will result in a longer overall duration of administration [dual primary end points].
Enrollment: Patients 18 years and older undergoing painful foot and/or ankle surgery will be offered enrollment.
Block placement: The nerve block site will be cleaned with chlorhexidine gluconate and isopropyl alcohol (ChloraPrep One-Step, Medi-Flex Hospital Products, Inc., Overland Park, KS, USA), and a clear, sterile, fenestrated drape applied. The ultrasound probe will be readied for use and placed to visualize the short-axis (cross-section) of the target nerve. A skin wheal will be raised at the catheter-placement needle's anticipated point of entry. An 8.9 cm, 17-gauge, insulated needle (FlexTip, Arrow International, Reading, PA, USA) will be used to place all perineural catheters. The catheter-placement 17G needle will be inserted through the skin wheal, advanced in-plane beneath the US transducer and directed toward the target nerve. Normal saline (1-2 mL) will be administered via the needle to open the space around the nerve.
A flexible non-stimulating perineural catheter (FlexTip, Arrow International, Reading, PA, USA) will be inserted 2-3 cm past the needle tip. After catheter insertion, Ropivacaine 0.5% (20 mL) will be administered via the catheter under ultrasound visualization. Sensation in the tibial and peroneal nerve distributions will be checked for anesthetic effect up to 15 minutes following initial local anesthetic bolus. A "successful" regional block will be defined as sensory- and motor-block onset in all expected nerve distributions within the 15 minutes following the local anesthetic injection.
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)
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
- •patients undergoing painful foot and/or ankle surgery with a planned popliteal sciatic perineural catheter for postoperative analgesia
- •age 18 years or older.
排除标准
- •Current daily opioid use within the previous 4 weeks
- •Clinical neuro-muscular deficit of either the sciatic nerve and its branches and/or innervating muscles
- •Morbid obesity [weight > 35 kg/m2]; surgery outside of ipsilateral sciatic and saphenous nerve distributions
- •Pregnancy [as determined by a urine pregnancy test prior to any study interventions]
- •Incarceration.
结局指标
主要结局
Average Pain Queried on First Postoperative Day
时间窗: postoperative day 1
Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.
Duration of Infusion
时间窗: 6 days postoperatively
Number of hours from the time the pump is initiated until local anesthetic reservoir exhaustion
次要结局
- Opioid Consumption(Each of 6 days postoperatively)
- Numbness in Foot and Ankle(Each of 6 days postoperatively)
- Worst Pain(Each of 6 days postoperatively)
- Average Pain(Each of 6 days postoperatively)
- Least Pain(Each of 6 days postoperatively)
- Current Pain(Each of 6 days postoperatively)
- Sleep Disturbances Due to Pain(Each of 6 nights postoperatively)
研究者
Brian M. Ilfeld, MD, MS
Professor in Residence
University of California, San Diego