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临床试验/NCT04858711
NCT04858711招募中不适用

The Effect of a Mixture of Dexmedetomidine-lidocaine-ketamine in One Syringe Versus Opioids on Recovery Profile and Postoperative Pain After Gynecological Laparoscopic Surgery

Aretaieion University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
pain score 6 hours postoperatively

研究概览

简要总结

The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic gynecological surgery

详细描述

Inadequately treated postoperative pain after gynecological surgery may untowardly affect early recovery and also lead to the development of chronic pain. Laparoscopic surgery is associated with diminished postoperative pain but this does not mean that patients subjected to laparoscopic operations are not in need for analgesia intra- and postoperatively. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia. Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay.

In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, dexmedetomidine is a highly selective alfa-2 adreno-ceptor agonist that provides sedation, analgesia, and sympatholysis. Its perioperative intravenous administration has been associated with a reduction in postoperative pain intensity, analgesic consumption and nausea.

There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations can be used towards the achievement of a completely opioid-free anesthetic regimen. Additionally, it can be hypothesized that the combination of non-opioid drugs with different targets can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of opioids.

Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine-ketamine-dexmedetomidine versus fentanyl on recovery profile, quality of recovery and postoperative pain after elective laparoscopic gynecological surgery.

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
25 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • adult female patients
  • American Society of Anesthesiologists (ASA) classification I-II
  • elective laparoscopic gynecological surgery

排除标准

  • body mass index (BMI) >35 kg/m2
  • contraindications to local anesthetic administration or non-steroidal agents 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-dexmedetomidine (KLD) group

Active Comparator

combination of ketamine-lidocaine-dexmedetomidine in one syringe

干预措施: ketamine-lidocaine-dexmedetomidine (Drug)

fentanyl (control) group

Active Comparator

syringe of fentanyl

干预措施: fentanyl (Drug)

结局指标

主要结局

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"

change from baseline in Quality of Recovery (QoR)-15 score after surgery

时间窗: 24 hours postoperatively

The QoR-15 is a quality of recovery scale that consists of 15 questions (items),including questions regarding pain (2 items), physical comfort (5 items), self-care ability (2 items), psychological support (2 items) and emotional state (4 items). Every item is scored on a scale of 10, with the lowest total score of 0 and the highest score of 150. The higher the score, the better the recovery quality of the patient

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 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 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 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

  • sevoflurane consumption during general anesthesia(change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2-3 hours)
  • time to first request for analgesia(during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively)
  • morphine consumption in Post-Anesthesia Care Unit (PACU)(immediately postoperatively)
  • tramadol consumption in the first 48 hours(48 hours postoperatively)
  • satisfaction from postoperative analgesia(24 hours postoperatively)
  • fentanyl requirement during surgery(intraoperatively)
  • Post Anesthesia Care Unit (PACU) duration of stay(immediately postoperatively)
  • sedation on arrival to Post-Anesthesia Care Unit(immediately postoperatively)
  • sedation at discharge from Post-Anesthesia Care (PACU) Unit(at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively)
  • sleep quality(24 hours postoperatively)
  • first mobilization after surgery(24 hours postoperatively)
  • gastrointestinal recovery after surgery(24 hours postoperatively)
  • hospitalization time(96 hours postoperatively)
  • side effects postoperatively(48 hours postoperatively)
  • incidence of chronic pain 1 month after surgery(1 month after surgery)
  • incidence of chronic pain 3 months after surgery(3 months after surgery)
  • first fluid intake(24 hours postoperatively)
  • first solid intake(24 hours postoperatively)
  • side effects intraoperatively(intraoperatively)

研究者

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

Dr Kassiani Theodoraki

Professor of Anesthesiology

Aretaieion University Hospital

研究点 (1)

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