Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
研究概览
简要总结
The objective of this study is to demonstrate that scalp nerve blocks ("scalp freezing"), performed at the end of supratentorial brain surgery, will reduce post-operative pain, opioids side effects, and the time required for post-anaesthesia care unit (PACU)/Intensive Care Unit (ICU) and hospital discharge.
详细描述
The proposed study is a randomized, placebo-controlled, triple-blinded, parallel-group clinical trial. Patients will be recruited from the neurosurgical population at St. Michael's Hospital.
The inclusion criteria are:
- Adults aged 18 years and over;
- scheduled for one of the following supratentorial craniotomy:
- resection of a brain tumour
- clipping of an un-ruptured cerebral aneurysm
- excision of an artero-venous malformation (AVM), or
- removal of an epileptic focus
- ASA physical status < IV
Intervention group: scalp nerve blocks with 20 ml of bupivacaine 0.5% + epinephrine 1:200,000 (divided among the different injection sites) at the end of surgery and before removal of the endo-tracheal tube. Control group: equal injections with 20 ml of saline + epinephrine 1:200,000 (at same time). In both study arms, post-operative rescue analgesia will be provided with hydromorphone patient-controlled analgesia (PCA).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18 years and over;
- •patients scheduled for elective craniotomy under general anaesthesia for one of the following surgeries:
- •resection of a supratentorial brain tumour,
- •clipping of an un-ruptured supratentorial cerebral aneurysm,
- •excision of a supratentorial arterio-venous malformation (AVM),
- •removal of an epileptic focus under general anaesthetic.
- •ASA physical status < IV.
排除标准
- •history of significant coronary artery disease (NYHA class III or IV) which would contraindicate the use of epinephrine;
- •presence of pain related to the intracranial pathology (e.g. tumour pain) since it could make difficult the discrimination between the tumour pain itself and the surgery related pain;
- •current history of alcohol abuse or recreational drug abuse;
- •active psychotic disorder;
- •history of chronic pain requiring chronic opioids use (patients on opioids for > 2 weeks);
- •known or suspected addiction to narcotic substances;
- •presence of any acute distracting pain;
- •history of migraines;
- •inability to understand or incapacity to use the VAS;
- •proven or suspected allergy to local anaesthetics;
- •craniotomy incision extending beyond the field of the block;
- •predicted need for postoperative ventilation;
- •history of scalp paresthesia or scalp scarring that may preclude normal nerve anatomy;
- •previous craniotomy or cranial irradiation;
- •history of malignant hyperthermia, which would contraindicate the anaesthesia maintenance protocol of this study;
- •pregnancy.
结局指标
主要结局
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
时间窗: 24 hours
次要结局
- 48h post-operative pooled VAS score(48 hours)
- the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours(24 and 48 hours)
- total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours(24 and 48 hours)
- the incidence of nausea and vomiting in the first 24 and 48 post-operative hours(24 and 48 hours)
- the time for patients to reach discharge eligibility from the PACU/ICU(Discharge time and date from PACU/ICU)
- the time for patients to reach discharge eligibility from hospital(Discharge time and date from hospital)
- presence of long term pain as measured with the Numeric Rating Scale (NRS) at days 5, 30 and 60 postoperatively(5, 30 and 60 days)
- Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5(day 5)