ERAS Approach for Post-Craniotomy Headache and Psychological Recovery

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

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 Overview

• Status: Completed
• Conditions: Post-Craniotomy Headache
• Intervention / Treatment: Drug: Scalp block with 0.5% plain Marcaine; Drug: dexmedetomidine; Drug: Intraoperative Analgesia

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 13511
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERAS Analgesia Group; Patients undergoing intracranial surgery receiving the suggested ERAS protocol.	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.
Active Comparator: Standard Opioid-Based Group; Patients undergoing intracranial surgery receiving conventional analgesic management.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2024
• Primary Completion (Actual): December 25, 2025
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 36264PR789/7/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No