跳至主要内容
临床试验/NCT05353764
NCT05353764Unknown不适用

Effect of Scalp Nerve Block Combined With Intercostal Nerve Block on Quality of Recovery After Deep Brain Stimulation in Patients With Parkinson's Disease

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
88
试验地点
1
主要终点
The 15-item QoR score

研究概览

简要总结

Patients diagnosed with Parkinson's disease (PD) undergoing deep Brain Stimulation (DBS) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (QoR) resulting in longer hospitalization time and higher hospital costs. Scalp nerve block (SNB) combined with intercostal nerve block (ICNB)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with PD was unclear. Therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after DBS surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • patients with PD who receive elective deep brain stimulation (DBS) surgery
  • Aged ≥ 18
  • American Society of Anesthesiologists (ASA) physical status of I-III
  • Able to communicate normally

排除标准

  • Allergy to local anesthetics
  • Pre-existing infection at block site
  • Severe coagulopathy
  • Pre-existing neuropathic pain condition
  • Previous history of DBS surgery
  • unwilling to provide informed consent or poor compliance

结局指标

主要结局

The 15-item QoR score

时间窗: 24 hour after surgery

The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery

次要结局

  • The patients with PONV(24 hour after surgery)
  • Consumption of opioid(during operation)
  • The 15-item QoR score(72 hour and 1 month after surgery)
  • The NRS score(before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery)

研究者

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

Wen-bin Lu, MD

Attending doctor

Changhai Hospital

研究点 (1)

Loading locations...

相似试验