REDUCE Trial: The Effects of Perineural Dexamethasone on Scalp Nerve Blocks for Relief of Postcraniotomy Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- The duration of analgesia
研究概览
简要总结
Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the backdrop of perioperative glucocorticoid deserves further clarification.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for elective supratentorial craniotomy under general anesthesia;
- •age 18 to 64 years;
- •an American Society of Anesthesiologists (ASA) physical status of I, II or III;
- •preoperative Glasgow Coma Scale (GCS) score of 15/15.
排除标准
- •History of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy;
- •Inability to understand or use the pain scales before surgery;
- •Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery;
- •Request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery;
- •Pregnancy or breastfeeding;
- •Extreme body mass index (BMI) (< 15 or > 35);
- •Participation in another interventional trial that interferes with the intervention or outcome of this trial;
- •Refusal or inability of the patient and/or legal guardian to provide informed consent;
- •Coagulopathy;
- •Infection around the puncture point;
- •History of allergies to any of the study drugs.
研究组 & 干预措施
Control group
The control group will receive scalp nerve blocks with 0.5% bupivacaine, plus normal saline with epinephrine at 1:200,000
干预措施: Bupivacaine (Drug)
DEX4mg group
DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine, plus 4 mg dexamethasone with epinephrine at 1:200,000.
干预措施: Dexamethasone combined with bupivacaine (Drug)
结局指标
主要结局
The duration of analgesia
时间窗: Within 48 hours after surgery
The time between the performance of the block and the administration of the first press the PCA demand button postoperatively.
次要结局
- Bradycardia(Within 48 hours after surgery)
- Postoperative nausea and vomiting (PONV)(Within 48 hours after surgery)
- Patient satisfaction score (PSS)(At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively)
- Sufentanil consumption(At 4, 12, 24 and 48 hours postoperatively)
- Glasgow Coma Scale (GCS)(At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively)
- Numeric rating scale (NRS)(At 2, 4, 8, 12, 16, 20, 24, and 48 hours postoperatively)
- Hypotension(Within 48 hours after surgery)
- The length of stay (LOS)(About at 2 weeks after surgery)
- Emergence delirium(Within 48 hours after surgery)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital