Liposomal Bupivacaine, Microvascular Decompression
Conditions
Keywords
Liposomal Bupivacaine, Microvascular decompression, scalp infiltration
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.
Interventions
DRUGliposomal bupivacaine local infiltration
Before the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine.
OTHERnormal operation
Following the normal procedure, after direct disinfection and draping, the incision operation can be carried out.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC NRS-R0-72 | 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
| Measure | Time frame | Description |
|---|---|---|
| The situation of emergency pain relief within 72 hours after the operation | 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) |
| 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 | Numerical rating scale（NRS) scores at 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after the operation |
| Hemodynamic data 1 | 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. |
| The time required for the first postoperative analgesic administration within 72 hours after the operation | From 0 to 72 hours after the operation | The time required for the first postoperative analgesic administration within 72 hours after the operation |
| QoR-15 score | At 72 hours after the operation | The 15-item quality of recovery scale at 72 hours after the operation |
| Length of hospital stay | From admission to discharge | The duration from admission to discharge |
| Hospital expenses | From admission to discharge | The medical expenses incurred from admission to discharge |
| Hemodynamic data 2 | 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. |
Contacts
Primary ContactWen Fan, M.A.
Outcome results
None listed