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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
139
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.
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.
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).
Tanta University
Tanta, El Gharbyia, Egypt
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).
Time frame: Immediately postoperative through 4 weeks of follow-up.
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).
Time frame: 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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