Effect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression

Официальное название

Effect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression: a Randomized Controlled Study

Обзор

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.

Вмешательства

• Препарат liposomal bupivacaine local infiltration
  Before the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine.
• Другое normal operation
  Following the normal procedure, after direct disinfection and draping, the incision operation can be carried out.

Первичные конечные точки

• AUC NRS-R0-72 [Срок оценки: From 0 to 72 hours after the operation]

Вторичные конечные точки (8)

• The time required for the first postoperative analgesic administration within 72 hours after the operation [Срок оценки: From 0 to 72 hours after the operation]
• The situation of emergency pain relief within 72 hours after the operation [Срок оценки: From 0 to72 hours after the operation]
• NRS scores at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after the operation [Срок оценки: From 0 to 72 hours after the operation]
• Hemodynamic data 1 [Срок оценки: From the time of incision to 1 hour after surgery]
• Hemodynamic data 2 [Срок оценки: From the time of incision to 1 hour after surgery]
• QoR-15 score [Срок оценки: At 72 hours after the operation]
• Length of hospital stay [Срок оценки: From admission to discharge]
• Hospital expenses [Срок оценки: From admission to discharge]

Критерии участия

Критерии включения

• (1) Age ≥ 18 years old;
• (2) ASA classification ≤ III grade, patients scheduled to undergo craniotomy and microvascular decompression surgery.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07245290 · 2025-1230

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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