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Liposomal Bupivacaine for Pain Relief in Microvascular Decompression Surgery

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Study Aim

This early phase study aims to evaluate if liposomal bupivacaine can effectively reduce pain in patients undergoing microvascular decompression surgery by observing pain levels over the first 72 hours after surgery.

What is being tested

liposomal bupivacaine local infiltration

+ normal operation

DrugOther
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactWen Fan, M.A.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2025

Actual date on which the first participant was enrolled.

This study is focused on improving pain management for patients who have undergone microvascular decompression surgery, a type of brain surgery. Many patients experience significant pain after such procedures, especially within the first two days. Traditional methods often use strong painkillers that can have unwanted side effects. This research is exploring the use of a new local anesthetic called liposomal bupivacaine, which is applied directly at the incision site. The goal is to see if this method can better manage pain by releasing the medication slowly over three days, potentially reducing the need for other pain medications and their side effects. Participants in this study are divided into two groups. One group receives liposomal bupivacaine directly at the incision site before the surgery starts, while the other group follows the usual practice without this local application. Researchers then track how effective the pain relief is by measuring the pain levels at rest over the first 72 hours after surgery. They also monitor when patients first ask for additional pain relief, the amount of rescue pain medication needed, and other health indicators like heart rate and blood pressure during and after the surgery. Additionally, the study examines the overall recovery experience and the length and cost of the hospital stay to see if this new method provides significant benefits.

Official TitleEffect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression: a Randomized Controlled Study
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactWen Fan, M.A.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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