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Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.
The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local analgesic techniques + dexmedetomidine group | Experimental | The patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. The patients also will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery. |
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| Local analgesic techniques and placebo dexmedetomidine group | Experimental | The patients in this group will be received scalp nerve block before surgery with 0.67 % liposomal bupivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery. |
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| Placebo local analgesic techniques and dexmedetomidine group | Experimental | The patients in this group will not receive scalp nerve block. The patients will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery. |
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| Placebo local analgesic techniques and placebo dexmedetomidine group | Placebo Comparator | The patients in this group will not receive scalp nerve block before surgery . For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine group during surgery and for 48 hours after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively. | Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively. | 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuming Peng, Dr | Contact | 8610-59976658 | florapym766@163.com | |
| Min Zeng, Dr | Contact | 15810617027 | fly800727@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuming Peng, Dr | Beijing Tiantan Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal saline | Drug | In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group |
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| Local analgesic techniques | Other | As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine |
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| no Local analgesic techniques | Other | No Local analgesic techniques will be given. |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |