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

Zhejiang University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Microvascular Decompression; Liposomal Bupivacaine

Treatments: Other: normal operation; Drug: liposomal bupivacaine local infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT07245290

2025-1230

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• (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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

For this group of patients, after routine disinfection and draping, the incision operation was performed directly.

Treatment:

Other: normal operation

Liposome bupivacaine group

Experimental group

Description:

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.

Treatment:

Drug: liposomal bupivacaine local infiltration