跳至主要内容
临床试验/NCT03650504
NCT03650504Unknown不适用

Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks

University of California, San Diego0 个研究点目标入组 40 人开始时间: 2018年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
AVERAGE PAIN

研究概览

简要总结

Adductor canal (AC) nerve block is a commonly used modality for postoperative pain control after total knee arthroplasty (TKA). When the adductor canal is viewed by ultrasound, the femoral artery and femoral vein can easily be identified, however, the nerve that is to be blocked is often not visible. For this reason, the femoral artery is used as a landmark for the block. There currently are no studies examining the optimal placement of the nerve block catheter relative to the femoral artery in the canal. The goal of this study will be to examine the relationship between nerve catheter tip location relative to femoral artery within the adductor canal for continuous AC nerve blocks. The investigators specifically will compare postoperative pain as well as incidence of vascular puncture during the procedure and time to complete the procedure for two different catheter locations.

详细描述

This will be a single-center, randomized, controlled investigation. Consenting adults undergoing unilateral total knee arthroplasty with a planned adductor canal perineural catheter will be offered enrollment. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF. Selection for inclusion will not be based on gender, race, or socioeconomic status.

Following written, informed consent, we will record baseline anthropomorphic information. All subjects will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned supine. Midazolam and fentanyl will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The ultrasound will be placed to visualize the short axis (cross-section) of the adductor canal. If both sites (above femoral artery versus between femoral artery and vein) are acceptable for catheter insertion, the subject will be randomized using a computer-generated list (blocks of 8) to one of two treatment groups in a 1:1 ratio using sealed, opaque, consecutively numbered envelopes: (1) above femoral artery vs (2) between femoral artery and vein.

Catheter insertion will adhere to current UCSD standard-of-care. The only difference for subjects participating in the study will be that the specific catheter insertion location will be determined randomly, instead of the physician simply choosing him/herself. All catheters will be placed by a regional anesthesia fellow under the direct supervision and guidance of a regional anesthesia attending. All catheters will be placed using standard UCSD perineural catheter techniques.

The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol, and a clear, sterile, fenestrated drape applied. The ultrasound probe will be placed to visualize the short-axis (cross-section) of the target nerve(s). A 17-gauge needle (FlexTip, Teleflex Medical, Triangle Research Park, NC, USA) will be used to place all perineural catheters. The catheter-placement needle will be inserted through the skin wheal, advanced in-plane beneath the US transducer and directed to the target nerve as described below:

"Above-the-artery": The needle will be directed below the nerve to about five o'clock of the artery. The needle will then be advanced to twelve o'clock of the artery while opening the adductor canal space with saline until adequate opening of the canal is realized. At that point, the catheter is placed above the artery.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing unilateral total knee arthroplasty at UC San Diego with planned placement of an adductor canal catheter at request of surgeon

排除标准

  • history of allergic reaction to lidocaine or ropivacaine
  • history of peripheral neuropathy, neuropathic pain, or chronic pain requiring opioid medications.
  • Pregnant females and prisoners

研究组 & 干预措施

Above Artery Group

Experimental

干预措施: Above Artery Catheter Placement (Procedure)

Between Artery and Vein Group

Active Comparator

干预措施: Between Artery and Vein Placement (Procedure)

结局指标

主要结局

AVERAGE PAIN

时间窗: 08:00AM to 24:00 on the first day following surgery

Average pain on post operative day 1 following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).

次要结局

  • Worst pain score (NRS 0-10 reported by patient)(Postoperative day , entire day)
  • Distance Ambulated(Physical Therapy sessions on postoperative day one)
  • Opioid consumption(Postoperative days zero and one)
  • Number of vascular pictures during placement(During the catheter placement procedure)
  • Total local anesthetic infused on first postoperative day(Postoperative days zero and one)
  • Intravascular injection assessed by heart rate response to epinephrine in injection(During the catheter placement procedure)
  • Procedure duration(Prior to surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John J. Finneran IV, MD

Assistant Clinical Professor

University of California, San Diego

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