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This randomized multicenter study involves patients undergoing intracranial surgeries (Population) to evaluate whether a perioperative analgesia protocol including scalp block (SB) with dexmedetomidine (DEX) infusion (Intervention) reduces the incidence and severity of post-craniotomy headache (PCH) compared to standard opioid-based perioperative analgesia (Comparison). The study aims to determine if this Enhanced Recovery After Surgery (ERAS) approach mitigates postoperative pain, reduces opioid consumption, and improves psychological outcomes, including anxiety, depression, and sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS Analgesia Group | Active Comparator | Patients undergoing intracranial surgery receiving the suggested ERAS protocol. |
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| Standard Opioid-Based Group | Active Comparator | Patients undergoing intracranial surgery receiving conventional analgesic management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalp block with 0.5% plain Marcaine | Drug | A regional anesthetic block targeting the major sensory nerves of the scalp (supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves). To provide dense, long-acting local analgesia to the surgical site, preventing the transmission of pain signals during the craniotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH). | Evaluation of the incidence and severity of PCH using the Visual Analogue Scale (VAS) and the Headache Impact Test-6 (HIT-6). | Immediately postoperative through 4 weeks of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Analgesic Regimen on Postoperative Cognitive Function (CF) | Evaluation of cognitive status using the Mini-Mental State Examination (MMSE). A score of <25 is used to define the presence of cognitive dysfunction (CD). | Assessed at three specific intervals: Baseline: Preoperatively (to establish the patient's normal function). POW2: Two weeks after surgery. POW4: Four weeks after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El Gharbyia | 13511 | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
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Both the investigators and the participants aren't aware of which arm the patient has been assigned to.
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| dexmedetomidine | Drug | Started intraoperatively and maintained as a continuous infusion until the end of the first postoperative day. To provide systemic analgesia, hemodynamic stability, and anxiolytic (anti-anxiety) effects to mitigate psychological distress and improve sleep quality post-surgery. |
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| Intraoperative Analgesia | Drug | Conventional opioid-based anesthesia. This typically involves the intravenous (IV) administration of strong opioids such as Fentanyl or Sufentanil to manage the intense pain during the craniotomy (bone flap removal) and dural opening. Intermittent boluses or continuous infusion of opioids as determined by the anesthesiologist based on the patient's hemodynamic response (heart rate and blood pressure). |
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