Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
研究概览
简要总结
This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.
详细描述
Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years old and less than 75 years years old
- •Horizontal abdominal incision
排除标准
- •Emergency or urgent procedure
- •Preexisting chronic pain (at any site) requiring treatment
- •Contraindication to any study medication (ketamine or lidocaine)
- •History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- •Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
- •Seizure disorder requiring medication within past 2 years
- •Planned spinal or epidural anesthesia or analgesia
研究组 & 干预措施
Lidocaine
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
干预措施: Lidocaine (Drug)
Placebo
A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
干预措施: Placebo (Drug)
Ketamine
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
干预措施: Ketamine (Drug)
ketamine + Lidocaine
both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.
干预措施: Ketamine + Lidocaine (Drug)
结局指标
主要结局
The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
时间窗: postoperative day 2
The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
次要结局
- Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2(PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2)
- Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2(intraoperative through postoperative day 2)
- Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day(2 hours after surgery, on postoperative day 1)
- Verbal Response Fatigue Score on Postoperative Day 1(postoperative day 1)