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Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Impact of Analgesic Regimen on Postoperative Cognitive Function (CF)
Assessed at three specific intervals: Baseline: Preoperatively (to establish the patient's normal function). POW2: Two weeks after surgery. POW4: Four weeks after surgery.

Study Arms (2)

ERAS Analgesia Group

ACTIVE COMPARATOR

Patients undergoing intracranial surgery receiving the suggested ERAS protocol.

Drug: Scalp block with 0.5% plain MarcaineDrug: dexmedetomidine

Standard Opioid-Based Group

ACTIVE COMPARATOR

Patients undergoing intracranial surgery receiving conventional analgesic management.

Drug: Intraoperative Analgesia

Interventions

Scalp block with 0.5% plain MarcaineDrug

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.

ERAS Analgesia Group

dexmedetomidineDrug

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.

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

Both the investigators and the participants aren't aware of which arm the patient has been assigned to.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Lecturer of Anesthesiology, Pain, and ICU Department

ERAS Approach for Post-Craniotomy Headache and Psychological Recovery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ERAS Analgesia Group

Standard Opioid-Based Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

ERAS Analgesia Group

Standard Opioid-Based Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations