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Completed

NCT Number: NCT07510217

ERAS Approach for Post-Craniotomy Headache and Psychological Recovery

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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Key information

Conditions

Post-Craniotomy Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing supratentorial or intracranial surgery;
  • signed informed consent.

Exclusion criteria

  • History of chronic headache disorders;
  • allergy to study medications;
  • emergency surgeries;
  • inability to perform psychological or cognitive testing.

Treatment and study plan

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.

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.

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).

Primary outcomes

  1. Success Rate of Treatment in Mitigating Post-Craniotomy Headache (PCH).

    Time frame: Immediately postoperative through 4 weeks of follow-up.

    Evaluation of the incidence and severity of PCH using the Visual Analogue Scale (VAS) and the Headache Impact Test-6 (HIT-6).

Secondary outcomes

  1. Impact of Analgesic Regimen on Postoperative Cognitive Function (CF)

    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.

    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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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