Effect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression: a Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- AUC NRS-R0-72
研究概览
简要总结
Background: Approximately 60-84% of patients undergoing craniotomy experience moderate to severe pain within 48 hours postoperatively, with posterior fossa craniotomy patients experiencing more severe pain. Microvascular decompression (MVD) is a type of posterior fossa surgery. Traditional analgesic regimens rely on intravenous opioids, but these have significant side effects. Currently, local infiltration at the incision site is a simple and effective analgesic method in multimodal analgesia protocols after craniotomy. Liposomal bupivacaine (Exparel®) is a new type of sustained-release local anesthetic. Its liposome encapsulation technology can extend the drug release time to 72 hours, covering the entire time window of postoperative acute pain and helping patients better control pain.
Objective: This study aims to explore the efficacy of local infiltration of liposomal bupivacaine at the scalp incision in acute pain after microvascular decompression in neurosurgery and provide evidence for clinical practice.
Methods: This study is a single-center, prospective, randomized controlled trial. A total of 100 patients scheduled for elective craniotomy for microvascular decompression will be enrolled. They will be randomly assigned to the liposomal bupivacaine incision infiltration group (LB group) or the conventional treatment control group (C group). After induction of general anesthesia, in the LB group, after preoperative disinfection and draping, the surgeon will perform layer-by-layer infiltration of the incision (subcutaneous → muscle → periosteum) before skin incision. In the C group, the routine procedure of direct disinfection and draping followed by skin incision will be performed. Both groups will receive standardized multimodal analgesia after returning to the ward. The primary outcome measure is the area under the curve of the numerical rating scale (NRS) for rest pain from 0 to 72 hours postoperatively (AUC NRS-R0-72). Secondary outcome measures include the time to first analgesic request within 72 hours postoperatively; rescue analgesia within 72 hours postoperatively (opioid analgesics converted to morphine milligram equivalents); NRS scores at 6, 12, 24, 48, and 72 hours postoperatively; hemodynamic data: heart rate and blood pressure at skin incision, 1 hour after skin incision, 2 hours after skin incision, at the end of surgery, and 1 hour postoperatively; QoR-15 score at 72 hours postoperatively; and length of hospital stay and hospitalization costs.
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
- 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
- •(1) Age ≥ 18 years old;
- •(2) ASA classification ≤ III grade, patients scheduled to undergo craniotomy and microvascular decompression surgery.
排除标准
- •(1) Trauma or emergency patients;
- •(2) Patients with cardiac conduction block (sinus node conduction block or atrioventricular conduction block);
- •(3) Patients with coagulation dysfunction;
- •(4) Patients who have abused alcohol or had severe dependence on anesthetic drugs within the past 2 months;
- •(5) Patients with uncontrolled anxiety disorder, schizophrenia or other mental illnesses;
- •(6) Patients with a history of allergy to local anesthetics or non-steroidal drugs.
研究组 & 干预措施
Control group
For this group of patients, after routine disinfection and draping, the incision operation was performed directly.
干预措施: normal operation (Other)
Liposome bupivacaine group
After the patients in this group underwent preoperative disinfection and draping, the surgical doctor gradually infiltrated the liposomal bupivacaine into the incision layer by layer (subcutaneous → muscle → periosteum), and then proceeded with the incision operation.
干预措施: liposomal bupivacaine local infiltration (Drug)
结局指标
主要结局
AUC NRS-R0-72
时间窗: From 0 to 72 hours after the operation
The area under the curve of the resting pain score from 0 to 72 hours after the operation
次要结局
- The situation of emergency pain relief within 72 hours after the operation(From 0 to72 hours after the operation)
- Length of hospital stay(From admission to discharge)
- Hospital expenses(From admission to discharge)
- The time required for the first postoperative analgesic administration within 72 hours after the operation(From 0 to 72 hours after the operation)
- NRS scores at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after the operation(From 0 to 72 hours after the operation)
- Hemodynamic data 1(From the time of incision to 1 hour after surgery)
- Hemodynamic data 2(From the time of incision to 1 hour after surgery)
- QoR-15 score(At 72 hours after the operation)