Pre-emptive Scalp Infiltration With Dexamethasone Lipid Microsphere Plus Ropivacaine for Postoperative Pain After Craniotomy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The pain NRS scores at 24 h after craniotomy
研究概览
简要总结
According to recent studies, patients following craniotomy suffer more than minimal pain; two-thirds of patients experienced moderate to severe pain. Postoperative pain most often occurs within 48 hours after surgery. Local infiltration of anesthesia is the most simple and effective analgesia. However, the analgesic effect only lasts for a short-time after surgery, and it cannot adequately meet the needs of postoperative analgesia after craniotomy. Several studies have shown that the mixture of dexamethasone with local anesthetics could reduce the postoperative pain scores better than local anesthetics alone. Lipid microsphere is a relatively new drug delivery system. It is an artificial lipid emulsion. Studies have shown that dexamethasone lipid microsphere, the dexamethasone palmitate emulsion (D-PAL emulsion), has stronger anti-inflammatory effect than dexamethasone. Therefore, the investigators hypothesize that the pre-emptive scalp infiltration with dexamethasone lipid microsphere plus ropivacaine could achieve superior postoperative pain-relief compared to ropivacaine alone for patients undergoing craniotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients scheduled for elective craniotomy under general anesthesia;
- •Age 18-64 years;
- •American Society of Anesthesiologists (ASA) physical status of I or II;
- •Anticipated tracheal extubation, full recovery and cooperation within 2 hours postoperatively
- •Patients required to fix their head in a head clamp during the operation.
排除标准
- •Previous history of craniotomy;
- •Plan to delay extubation or no plan to extubate;
- •Patients who cannot use the patient-controlled analgesia (PCA) device;
- •Patients who cannot comprehend the instructions of a numeric rating scale (NRS) before craniotomy;
- •Body mass index (BMI) <15 or >35;
- •Allergy to dexamethasone, lipid microsphere, opioids or ropivacaine;
- •History of drug abuse or excessive alcohol, chronic opioids use (more than 2 weeks), or use of any sedative or analgesic before surgery;
- •History of uncontrolled epilepsy, psychiatric disorders or chronic headache;
- •Pregnant or at breastfeeding;
- •Symptomatic cardiopulmonary, liver or renal dysfunction or combined with diabetes or other systemic dysfunction;
- •Glasgow Coma Scale <15 before the surgery;
- •Intracranial hypertension;
- •Peri-incisional infection;
- •Patients who have received chemoradiotherapy before the surgery or expected to receive postoperative chemoradiotherapy according to the preoperative imaging.
研究组 & 干预措施
The dexamethasone lipid microsphere plus ropivacaine group
干预措施: Dexamethasone lipid microsphere plus ropivacaine (Drug)
The ropivacaine alone group
干预措施: Ropivacaine alone (Drug)
结局指标
主要结局
The pain NRS scores at 24 h after craniotomy
时间窗: At 24 hours after the operation
The numeral rating scale allows a person to describe the intensity of the pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be".
次要结局
- The incidence of PONV(Within 24, 48, 72 hours after surgery)
- WHOQOL-BREF scores(At 1 month and 3 months after surgery)
- The NRS score(At 2 hours, 4 hours, 12 hours, 48 hours, 72 hours, 1 month, and 3 months after the operation)
- Adverse events(Through the whole follow-up, an average of 3 months)
- The number of patients who didn't press the PCA button(Within 24, 48, 72 hours postoperatively)
- The number of times patients press the PCA button(Within 24, 48, 72 hours postoperatively)
- Time to first rescue analgesia with OC/APAP after surgery(At 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively)
- Wound healing scores(At 1 and 3 months after surgery)
- The first time the patients press the PCA button(Within 24, 48,72 hours postoperatively)
- Duration of hospitalization(From the date of the surgery until the date of discharge, assesses up to 7 days)
- Cumulative sufentanil consumption by PCA device(During 24hours, 48 hours and 72 hours postoperatively)
- POSAS scores(At 3 months after surgery)
研究者
Fang Luo
Director of Department of Day Surgery and Pain Management
Beijing Tiantan Hospital