Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery: A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization
研究概览
简要总结
The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomy/fusion when compared to placebo
Opioid dependence will be defined as daily opioid use (2 or more doses per day) for a period of two-months or longer. Intraoperatively, patients will receive a 1 mg/kg dose of intravenous ketamine or saline with 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr or saline will be run to conclude at 24 hours after the end of the surgery (fascial closure). The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively. Secondary outcome measures will be VAS pain scores at rest and with movement in PACU, 24 hr, 48 hr, 72 hr, 2 week (post-op visit), 6 week follow-up visit, as well as, McGill Pain Questionnaire, Pain Catastrophizing Scale, and emotional distress surveys assessing depression and anxiety at preop/screening, postop and 6 week follow-up (PROMIS Emotional Distress-Anxiety Short Form, PROMIS Emotional Distress-Depression Short Form), as well as a Neuro-QOL Short Form v1.1 - Satisfaction with Social Roles and Activities .
详细描述
Patients will be recruited from the University of Pittsburgh Medical Center (UPMC) Neurosurgery Clinic and Operating Room Schedule. The primary surgeon will identify patients who would be eligible for inclusion, ask them if they would be interested in participating, and if so, the enrollment and consent process would be initiated. The participating neurosurgeons include Dr. Okonkwo and Dr. Hamilton, who have agreed to allow us access to their patients. Informed consent will be performed by the surgeon or the PI. Enrollment will be performed by the study coordinator and/or trained representative from the Acute Interventional Perioperative Pain Service (AIPPS). Enrollment will include review of eligibility, and detailed explanation of the study.
Screening Visit:
After patients are enrolled into the study at the preoperative neurosurgery clinic, a number of forms will be filled out by the participants: McGill Pain questionaire-Short form, pain medication review form, and the Pain Catastrophizing Scale (PCS) (Sullivan, 1995). PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form, Brief Psychiatric Rating Scale and Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities will also be completed.
Pre-Operative Visit:
The participant will be asked to come into the Aiken Medical Building, Suite 407 on a date after the clinic visit but before their day of surgery for a Pre-Operative Visit. Investigators will work with the participant to determine their opioid dose regimen, and the participant will be asked to come into the Aiken Medical Building thirty minutes before their opioid dose is due and will be asked to bring with them their upcoming dose of pain medication. Prior to taking their pain medication, the participant will then be administered a cold-pressor pain sensitivity test. Heart rate and blood pressure will be recorded before and after the cold-pressor test. Once the cold pressor test is completed, the McGill Pain Questionnaire will be administered. After this questionnaire is complete, the participant will take the dose of opioid medication they have brought from home and are scheduled to receive and will wait in the clinic for 30 minutes for the pain medication to take effect. Once the 30 minutes is complete, the cold-pressor test will be repeated, heart rate and blood pressure collected before and after, and McGill Pain Questionnaire will be administered again.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine Group
Participants will receive a 1 mg/kg dose of intravenous ketamine 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr ketamine with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
干预措施: Ketamine (Drug)
Placebo Group
Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure).
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Post-surgical Hydromorphone Patient Care Assistance (PCA) Opioid Utilization
时间窗: 72 hours postoperatively
Hydromorphone Patient Care Assistant (PCA) usage during the first 72 hours postoperatively will be recorded. Hydromorphone opioid usage will be assessed and converted to morphine equivalents/24 hour. The higher the values, the worse the outcomes.
Post-surgical Pain Rating Using the Visual Analog Scale (VAS)
时间窗: 72 hours post-operatively
Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. The participant will be asked to score pain at its best and worst over the period since they were last asked. Higher scores present a worse outcome. Pain will be monitored every four hours from the time the participant enters the PACU until discharge from the hospital, except during the night when the participant is asleep. The value reported consists of the average of all pain scores collected.
Post-surgical Opioid Utilization Using Electronic Medication Review
时间窗: 6-week follow-up visit
Post-surgical opioid utilization will be measured by reviewing participant's electronic medical records and recording opioid usage. Daily opioid usage will be assessed and converted to morphine equivalents/24 hr. The higher the values, the worse the outcomes.
Pre-surgical Pain Rating Using the Visual Analog Scale (VAS)
时间窗: Screening visit
Post-surgical pain ratings will be measured by the assessment of participant's answers to the Visual Analog Scale (VAS). This measurement is a visual scale from 0-10, 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores present a worse outcome.
Pre-surgical Opioid Utilization Using the Pain Medication Review Form
时间窗: Screening visit
Pre-surgical opioid utilization will be measured by the Pain Medication Review Form where patients will record all of the medications they are currently taking.
次要结局
- Pre-surgical Emotional Distress Related to Depression(Screening visit)
- Post-surgical Emotional Distress Related to Depression(6-week follow-up visit)
- Pre-surgical Emotional Distress Related to Anxiety(Screening visit)
- Post-surgical Emotional Distress Related to Anxiety(6-week follow-up visit)
- Post-surgical Satisfaction With Social Roles and Activities(6-week follow-up visit)
- Pre-surgical Pain Rating Using the Pain Catastrophizing Scale(Screening visit)
- Post-surgical Pain Rating Using the Pain Catastrophizing Scale(6-week follow-up visit)
- Pre-surgical Satisfaction With Social Roles and Activities(Screening visit)
- Pre-surgical Opioid Analgesic Efficacy Using the Cold-Pressor Pain Sensitivity Test(Screening visit)
- Post-surgical Opioid Analgesic Efficacy Using the Cold-Pressor Pain Sensitivity Test(6-week follow-up visit)
研究者
Jacques E. Chelly
Professor of Anesthesiology and Perioperative Medicine and Orthopedic Surgery Director, Regional Anesthesiology Fellowship Program
University of Pittsburgh