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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | For this group of patients, after routine disinfection and draping, the incision operation was performed directly. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivacaine local infiltration | Drug | Before the operation, local infiltration of the scalp incision was performed using liposomal bupivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC NRS-R0-72 | The area under the curve of the resting pain score from 0 to 72 hours after the operation | From 0 to 72 hours after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 0 to 72 hours after the operation |
| The situation of emergency pain relief within 72 hours after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Fan, M.A. | Contact | 86-13738142076 | mosquitofw@qq.com |
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| normal operation | Other | Following the normal procedure, after direct disinfection and draping, the incision operation can be carried out. |
|
The situation of emergency pain relief within 72 hours after the operation(Converting the dosage of opioid painkillers into milligram equivalents of morphine) |
| 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 | 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. | 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. | 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 | At 72 hours after the operation |
| Length of hospital stay | The duration from admission to discharge | From admission to discharge |
| Hospital expenses | The medical expenses incurred from admission to discharge | From admission to discharge |