NCT07510217

ERAS Approach for Post-Craniotomy Headache and Psychological Recovery

Enhanced Recovery After Surgery Approach May Mitigate Post-craniotomy Headache and Psychological Derangement

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post-Craniotomy Headache

Interventions

Type	Name	Description
DRUG	Scalp block with 0.5% plain Marcaine	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.
DRUG	dexmedetomidine	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.
DRUG	Intraoperative Analgesia	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).

Timeline

• Start date: 2024-08-10
• Primary completion: 2025-12-25
• Completion: 2026-02-20
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Egypt