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NCT Number: NCT07245290

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liposomal bupivacaine local infiltration

Drug

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

normal operation

Other

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

Primary outcomes

  1. AUC NRS-R0-72

    Time frame: 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

Secondary outcomes

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

    Time frame: From 0 to 72 hours after the operation

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

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

    Time frame: From 0 to72 hours after the operation

    The situation of emergency pain relief within 72 hours after the operation(Converting the dosage of opioid painkillers into milligram equivalents of morphine)

  3. NRS scores at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after the operation

    Time frame: From 0 to 72 hours after the operation

    Numerical rating scale(NRS) scores at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after the operation

  4. Hemodynamic data 1

    Time frame: From the time of incision to 1 hour after surgery

    Heart rate at the time of incision, 1 hour after incision, 2 hours after incision, at the end of the surgery, and 1 hour after surgery.

  5. Hemodynamic data 2

    Time frame: From the time of incision to 1 hour after surgery

    Blood pressure at the time of incision, 1 hour after incision, 2 hours after incision, at the end of the surgery, and 1 hour after surgery.

  6. QoR-15 score

    Time frame: At 72 hours after the operation

    The 15-item quality of recovery scale at 72 hours after the operation

  7. Length of hospital stay

    Time frame: From admission to discharge

    The duration from admission to discharge

  8. Hospital expenses

    Time frame: From admission to discharge

    The medical expenses incurred from admission to discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Wen Fan, M.A.

CONTACT

[email protected]

86-13738142076

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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