Liposomal BupivacaineEarly Phase 1NCT07245290
Effect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression
A Early Phase 1 study testing liposomal bupivacaine local infiltration and normal operation in people with Liposomal Bupivacaine and Microvascular Decompression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liposomal Bupivacaine, Microvascular Decompression
- What is being tested?
- liposomal bupivacaine local infiltration and normal operation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age ≥ 18 years old;
- (2) ASA classification ≤ III grade, patients scheduled to undergo craniotomy and microvascular decompression surgery.
Who cannot join
- (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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression: a Randomized Controlled Study
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
- Being tested
- liposomal bupivacaine local infiltration, normal operation
- Keywords
- Liposomal Bupivacaine, Microvascular decompression, scalp infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaine local infiltrationDrug
Before the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine.
normal operationOther
Following the normal procedure, after direct disinfection and draping, the incision operation can be carried out.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | For this group of patients, after routine disinfection and draping, the incision operation was performed directly. Receives: 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. Receives: Drug: liposomal bupivacaine local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC NRS-R0-72
The area under the curve of the resting pain score from 0 to 72 hours after the operation
Measured: 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
The time required for the first postoperative analgesic administration within 72 hours after the operation
Measured: From 0 to 72 hours after the operation
The situation of emergency pain relief within 72 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)
Measured: From 0 to72 hours after the operation
NRS scores at 6 hours, 12 hours, 24 hours, 48 hours, and 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
Measured: From 0 to 72 hours after the operation
Hemodynamic data 1
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.
Measured: From the time of incision to 1 hour after surgery
Hemodynamic data 2
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.
Measured: From the time of incision to 1 hour after surgery
QoR-15 score
The 15-item quality of recovery scale at 72 hours after the operation
Measured: At 72 hours after the operation
Length of hospital stay
The duration from admission to discharge
Measured: From admission to discharge
Hospital expenses
The medical expenses incurred from admission to discharge
Measured: From admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liposomal BupivacaineStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245290
- Sponsor's protocol ID
- 2025-1230
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Infiltration of Liposomal Bupivacaine on Postoperative Analgesia in Patients With Craniotomy Microvascular Decompression: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07245290
- Acronym / sponsor ID
- 2025-1230
- Conditions
- Liposomal Bupivacaine, Microvascular Decompression
- Keywords
- Liposomal Bupivacaine, Microvascular decompression, scalp infiltration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: normal operationFor this group of patients, after routine disinfection and draping, the incision operation was performed directly. |
| Liposome bupivacaine group | Experimental | Drug: liposomal bupivacaine local infiltrationAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1) Age ≥ 18 years old;
- (2) ASA classification ≤ III grade, patients scheduled to undergo craniotomy and microvascular decompression surgery.
Key exclusion criteria (6 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal bupivacaine local infiltrationBefore the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine. | Drug | Liposome bupivacaine group |
| normal operationFollowing the normal procedure, after direct disinfection and draping, the incision operation can be carried out. | Other | Control group |
Primary outcome
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
8 secondary outcomes
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 situation of emergency pain relief within 72 hours after the operation
Time frame: From 0 to72 hours after the operation
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
Hemodynamic data 1
Time frame: From the time of incision to 1 hour after surgery
Hemodynamic data 2
Time frame: From the time of incision to 1 hour after surgery
QoR-15 score
Time frame: At 72 hours after the operation
Length of hospital stay
Time frame: From admission to discharge
Hospital expenses
Time frame: From admission to discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing liposomal bupivacaine local infiltration and normal operation in people with Liposomal Bupivacaine and Microvascular Decompression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Fan, M.A. (86-13738142076, mosquitofw@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC NRS-R0-72 (time frame: From 0 to 72 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.