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临床试验/NCT05160493
NCT05160493已完成2 期

The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2021年12月20日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
246
试验地点
1
主要终点
Proportion of craniotomy patients with NRS score greater than one 3 months after surgery

研究概览

简要总结

Chronic postsurgical pain (CPSP), which is one of the most common and serious long term complication of surgery,occurs in approximately 10% of patients after a surgical procedure. Craniotomy was previously considered to have less chronic pain than other surgical procedures. Contrarily, studies have reported incidences of chronic headache varies for type of craniotomy, ranging from 23% to 34% at three months and 12% to 16% at one year after surgery. In addition,CPSP is associated with adverse events, including postoperative morbidity, increased health-care costs, significant impaired on quality of life, prolonged opioid use. Optimising perioperative pain management should reduce the incidence of CPSP; The non-opioid analgesics, such as ketamine and pregabalin, have also been used as components of multimodal anesthetic protocols. Postoperative pain scores and opioid use are significantly reduced in thoracotomy surgical patients given ketamine and pregabalin compared to control groups.however, there is currently a lack of evidence regarding which therapeutic options are most effective in reducing the incidence of chronic post-craniotomy headache. The investigators hypothesis is that sketamine combined with pregabalin reduces significantly chronic postoperative pain after craniotomy and improves patient outcome.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, age ≥18 years, male or female
  • American Society of Anaesthesiology (ASA) status I-III
  • Patients undergoing elective craniotomy

排除标准

  • Patients unable to complete scale assessment
  • Pregnant or lactating women
  • Patients with preoperative chronic pain syndrome
  • Patients with previous craniotomy history
  • Patients with a history of mental illness who are receiving medication
  • Patients with liver and kidney dysfunction
  • Patients have taken pain medication within two weeks
  • Patients with history of adverse reactions to pregabalin, ketamine and esticketamine
  • Patients with history of drug abuse;
  • BMI>35.0 kg · m - 2.

研究组 & 干预措施

S-ketamine and pregabalin

Experimental

Drug: S-ketamine and pregabalin

  • Drug: Pregabalin 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7),followed by dose reduction to 75mg once daily for 7days(POD8-14)
  • Drug: S-ketamine infusion 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h

干预措施: S-ketamine and pregabalin (Drug)

Normal saline and placebo capsule

Placebo Comparator

Drug: Normal saline and placebo capsule

  • Drug: Placebo capsules :Two placebo capsules(2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days
  • Drug: Normal saline• 0.9% saline bolus after induction of anesthesia +intravenous infusion for 48 hours

干预措施: Normal saline and placebo capsule (Drug)

结局指标

主要结局

Proportion of craniotomy patients with NRS score greater than one 3 months after surgery

时间窗: 3 months after surgery

次要结局

未报告次要终点

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

Professor

Beijing Tiantan Hospital

研究点 (1)

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