Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain Status as Measured by Numeric Pain Scale
研究概览
简要总结
The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee arthroplasty can be observed with the substitution of a post operative adductor canal block for a preoperative adductor canal block in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, 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
- •1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent
排除标准
- •All patients under the age of 18
- •Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women planning on becoming pregnant in the next year, and women who think they might be pregnant.
- •Patients with prior surgery or history of infection on the joint of interest.
- •Patients on steroid preoperatively.
- •Inability to provide medical consent.
- •Patients with a history of significant unmitigated pain in parts of their body not including the knee the procedure is to be performed or a history of pain catastrophizing (the tendency to magnify the threat value of the pain stimulus and to feel helpless in the context of pain, and by a relative inability to inhibit pain-related thoughts in anticipation of, during or following a painful event) regarding pain anywhere in the body.
- •Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
- •Allergy to local anesthetic or any medication used in the standard protocol for joint replacement.
研究组 & 干预措施
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Dexamethasone (Drug)
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Acetaminophen (Drug)
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Lyrica (Drug)
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Celebrex (Drug)
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Meloxicam (Drug)
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Oxycodone (Drug)
Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
干预措施: Ropivacaine (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Dexamethasone (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Acetaminophen (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Lyrica (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Celebrex (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Meloxicam (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Oxycodone (Drug)
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain Status as Measured by Numeric Pain Scale
时间窗: 24 hours postoperatively
Scale with numeric scores ranging from 0 (least) to 10 (most) pain
次要结局
- Episodes of Nausea(24 hours postoperatively)
- Episodes of Vomiting(24 hours postoperatively)
- Discharges by Midnight on POD1(Up to 48 hours postoperatively)
- Patients Reporting Nausea(24 hours postoperatively)
- Hours Hospitalized(Up to 336 hours postoperatively)
- Discharges by Midnight POD0(Up to 24 hours postoperatively)
- Patients Reporting Vomiting(24 hours postoperatively)
- Total Opioid Consumption(24 hours postoperatively)
- Nights Hospitalized(Up to 14 nights postoperatively)
研究者
Victor Hugo Hernandez
Professor of Clinical
University of Miami