An Early Phase 1 interventional study of liposomal bupivacaine local infiltration and normal operation in Liposomal Bupivacaine and Microvascular Decompression, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Early Phase 1, Interventional, and Prevention
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.
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For this group of patients, after routine disinfection and draping, the incision operation was performed directly.
Other: normal operation
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
Before the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine.
Following the normal procedure, after direct disinfection and draping, the incision operation can be carried out.
AUC NRS-R0-72
The area under the curve of the resting pain score from 0 to 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
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
The situation of emergency pain relief within 72 hours after the operation(Converting the dosage of opioid painkillers into milligram equivalents of morphine)
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
Numerical rating scale（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
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.
Time frame: 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.
Time frame: 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
Time frame: At 72 hours after the operation
Length of hospital stay
The duration from admission to discharge
Time frame: From admission to discharge
Hospital expenses
The medical expenses incurred from admission to discharge
Time frame: From admission to discharge
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University