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

NCT07245290 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025-1230
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liposomal Bupivacaine; Microvascular Decompression

Keywords

Liposomal Bupivacaine; Microvascular decompression; scalp infiltration

Outcome Measures

Primary Outcomes (1)

• AUC NRS-R0-72

  The area under the curve of the resting pain score from 0 to 72 hours after the operation

  From 0 to 72 hours after the operation

Secondary Outcomes (8)

• The time required for the first postoperative analgesic administration within 72 hours after the operation

  From 0 to 72 hours after the operation

• The situation of emergency pain relief within 72 hours after the operation

  From 0 to72 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Other: normal operation

Liposome bupivacaine group

EXPERIMENTAL

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.

Drug: liposomal bupivacaine local infiltration

Interventions

liposomal bupivacaine local infiltration DRUG

Before the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine.

Liposome bupivacaine group

normal operation OTHER

Following the normal procedure, after direct disinfection and draping, the incision operation can be carried out.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Central Study Contacts

Wen Fan, M.A.

CONTACT

86-13738142076; mosquitofw@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share