Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Chronic post-craniotomy pain
研究概览
简要总结
Objective: To compare the incidence of chronic pain at 3 months among adults undergoing craniotomy between those received two different doses of pregabalin and those receiving placebo.
详细描述
Hypothesis
Perioperative pregabalin will reduce the incidence of chronic post-operative pain, and will reduce the opioid consumption, opioid-related side effects, and hospital length of stay compared with placebo in patients undergoing elective craniotomy.
Methods: 316 adults (18-65y), ASA I-III, undergoing elective craniotomy will be randomized to receive: 100mg or 150mg pregabalin or placebo once pre-operatively and 50mg or 75mg or placebo twice daily for 14 post-operative days. NRS pain scores, opioid consumption and side effects will be assessed up to 48h, and long-term pain at days 7, 14, 30, and 90. The primary analysis will involve the comparison between the 2 treatment groups together vs. placebo. A stepwise method will be used to evaluate the pairwise comparisons.
Outcomes: The primary outcome will be the incidence of chronic post-craniotomy pain at 3 mos. Important secondary outcomes are: neuropathic component of pain at 3 mos., total opioid consumption in the first 24h, and incidence and severity of opioid-related side effects at days 1, 2 and 7.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 18 to 65 years (limited to 65 years to lower the risk of over-sedation for elderly patients)
- •Undergoing elective craniotomy (supratentorial or infratentorial) under general anaesthesia for: biopsy or resection of a tumour, clipping of an unruptured aneurysm, or excision of an arteriovenous malformation
- •ASA physical status I-III
排除标准
- •predicted need for prolonged post-operative ventilation (> 12 hours)
- •chronic pain secondary to previous craniotomy
- •known adverse reaction to drugs used (gabapentin, pregabalin, hydromorphone, and/or acetaminophen)
- •prior use of pregabalin or gabapentin (within 2 weeks before surgery)
- •current history of moderate to severe headaches (NRS ≥ 4) related to intracranial pathology (tumour pain) since it may be difficult to discriminate between ongoing tumour pain and surgery-related post-operative pain
- •current history of migraines
- •pre-existing chronic pain requiring chronic opioid use (30mg morphine equivalent within 4 weeks of surgery)
- •currently taking any drug that could interact with pregabalin
- •current history of alcohol or recreational drug abuse
- •known or suspected addiction to narcotic substances or chronic narcotic use in the last 2 weeks
- •history of malignant hyperthermia (contraindicates the anaesthesia protocol of this study)
- •history of angioedema
- •Body Mass Index ≤ 18.4 or ≥ 35
- •history of untreated obstructive sleep apnea
- •any condition that would contraindicate the use of patient-controlled analgesia (PCA)
- •lacks fluency in English
- •pre-existing renal impairment (for pregabalin elimination)
- •pregnancy
研究组 & 干预措施
Pregabalin 100 mg
干预措施: pregabalin (Drug)
pregabalin 150 mg
干预措施: pregabalin (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Chronic post-craniotomy pain
时间窗: 3 months
The primary outcome of this study will be the incidence of chronic post-craniotomy pain at 3 months
次要结局
- length of hospital stay(30 days)
- neuropathic component of the pain at 3 months(3 months)
- post-operative pain scores at 48h(48 hours)
- incidence and severity of opioid-related side effects at day 2(Day 2)
- incidence of long-term pain at days 7(Day 7)
- incidence of long-term pain at day 14(Day 14)
- incidence of long-term pain at day 30(Day 30)
- total opioid consumption in the first 24h(24 hours)
- total patient-controlled analgesia (PCA)demands and delivered doses in 24h(24 hours)
- post-operative pain scores at 24h(24 hours)
- incidence and severity of opioid-related side effects at Day 7(Day 7)
- consumption of antiemetics in the first 24h(24 hours)
- tracheal extubation time(within 24 hours)