The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain score at discharge from Post-Anesthesia Care Unit (PACU)
研究概览
简要总结
The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.
详细描述
Cervical spine surgery is associated with medium pain scores and perioperative disability. Ketamine and lidocaine have all proven but varied analgesic effects. High opioid consumption has been associated with multiple side effects.
This double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine and lidocaine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Ketamine-Lidocaine (KL) group will receive a continuous infusion of ketamine and lidocaine, during the surgery and shortly after.
Both infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.
Multiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patents
- •American Society of Anesthesiologists (ASA) class I-III
- •elective spine surgery
排除标准
- •body mass index (BMI) >35 kg/m2
- •contraindications to local anesthetic administration
- •systematic use of analgesic agents preoperatively
- •chronic pain syndromes preoperatively
- •neurological or psychiatric disease on treatment
- •pregnancy
- •severe hepatic or renal disease
- •history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
- •bradycardia(<55 beats/minute)
- •drug or alcohol abuse
- •language or communication barriers lack of informed consent
研究组 & 干预措施
ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe
干预措施: ketamine-lidocaine (Drug)
: remifentanil group syringe of remifentanil
干预措施: Remifentanil (Drug)
结局指标
主要结局
pain score at discharge from Post-Anesthesia Care Unit (PACU)
时间窗: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score on arrival to Post-Anesthesia Care Unit (PACU)
时间窗: immediately postoperatively]
pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 3 hours postoperatively
时间窗: 3 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 6 hours postoperatively
时间窗: 6 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
pain score 24 hours postoperatively
时间窗: 24 hours postoperatively
pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
次要结局
- tramadol consumption in the first 48 hours(48 hours postoperatively)
- time to first request for analgesia(during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively)
- sedation at discharge from Post-Anesthesia Care (PACU) Unit(at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively)
- morphine consumption in Post-Anesthesia Care Unit (PACU)(immediately postoperatively)
- satisfaction from postoperative analgesia(24 hours postoperatively)
- sedation on arrival to Post-Anesthesia Care Unit(immediately postoperatively)
- fentanyl requirement during surgery(intraoperatively)
研究者
Athanasios Vaiopoulos
Anesthesia Resident
Evangelismos Hospital