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Hydrocortisone trial protocol evaluates postoperative headache and opioid use in hemifacial spasm surgeryTrial Plans to Test Hydrocortisone for Postoperative Headache Relief

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Key Takeaway
Note that this is a trial protocol; no results are available as recruitment has not yet commenced.

This trial protocol outlines a planned study to evaluate the impact of intravenous hydrocortisone on postoperative outcomes for patients aged 18 to 70 years undergoing elective microvascular decompression (MVD) for primary hemifacial spasm. The study aims to assess whether hydrocortisone reduces headache intensity and opioid requirements following surgery.

The proposed intervention involves intravenous hydrocortisone (100 mg at induction, then days 1 to 2) compared to a matching placebo. The primary outcomes are mean postoperative headache intensity on a visual analogue scale during days 1 to 3 and 72-h cumulative rescue opioid consumption in oral morphine milliequivalents. Secondary outcomes include recovery parameters, inflammatory biomarkers, and long-term hemifacial spasm control.

As this is a trial protocol, no results are currently available. The study has not yet commenced recruitment, and no data regarding efficacy or safety can be synthesized at this time. The study will include a 30-day follow-up for safety and a 6-month follow-up for long-term outcomes.

How this fits prior evidence

This trial protocol addresses a gap in management for postoperative pain and opioid consumption following microvascular decompression for hemifacial spasm. It does not relate to previous findings regarding hydrocortisone in preterm infants, critically ill patients, Cushing Syndrome, Triple A syndrome, or regional nerve blocks.

Researchers are planning a study to help patients undergoing a specific surgery called microvascular decompression. This procedure is performed to treat a condition known as hemifacial spasm. The goal of the study is to see if giving patients intravenous hydrocortisone can make their recovery more comfortable.

The study will involve 100 patients between the ages of 18 and 70. These patients will be given either hydrocortisone or a placebo. The researchers want to measure how much pain the patients feel from headaches and how much morphine they need to take during the first few days after their surgery.

Because this is a trial protocol, the study has not started yet and there are no results to share. The researchers will also track other factors like inflammation markers and long-term quality of life. While hydrocortisone can cause side effects like high blood sugar or infection, the study aims to determine if it provides a safer way to manage immediate post-surgical pain.

What this means for you:
This planned study will test if hydrocortisone reduces headache pain and opioid use after hemifacial spasm surgery.

Common questions

What is the goal of this study?

The study aims to see if intravenous hydrocortisone can reduce the intensity of headaches and the amount of morphine needed by patients after they undergo surgery for hemifacial spasm. It also looks at other factors like recovery time and long-term quality of life.

Who is eligible for this trial?

The study is designed for patients between the ages of 18 and 70 who are undergoing elective microvascular decompression for primary hemifacial spasm. The trial will involve a total of 100 participants.

Are there any known risks with the treatment?

The study notes that hydrocortisone can lead to certain side effects, including infection, hyperglycemia, and psychiatric symptoms. Patients should discuss these potential risks and their specific medical history with their doctor.

Study Details

Study typeSystematic review
EvidenceLevel 1
PublishedNov 2026
View Original Abstract ↓
BackgroundMicrovascular decompression (MVD) for hemifacial spasm triggers substantial perioperative stress and inflammatory responses that may contribute to early postoperative symptoms and potentially influence long-term surgical outcomes. Perioperative corticosteroids can modulate these responses, but their efficacy and safety in this specific neurosurgical population remain inadequately characterized. This trial aims to evaluate whether short-course perioperative hydrocortisone reduces early postoperative symptom burden and to explore its effects on biomarker dynamics and long-term efficacy.MethodsThis single-center, randomized, assessor-blinded, controlled trial will enroll 100 patients aged 18–70 years undergoing elective MVD for primary hemifacial spasm. Participants will be allocated 1:1 to receive either intravenous hydrocortisone (100 mg at induction, then days 1–2) or matching placebo. Primary outcomes are mean postoperative headache intensity (visual analogue scale, days 1–3) and 72-h cumulative rescue opioid consumption (oral morphine milligram equivalents). Secondary outcomes include recovery parameters, postoperative symptoms, and inflammatory biomarkers (interleukin-6, C-reactive protein, S100B), with serum cortisol reported only as a descriptive drug exposure variable. Long-term hemifacial spasm control and quality of life at 6 months will be explored. Safety monitoring includes infection, hyperglycemia, and psychiatric symptoms through 30 days. Intention-to-treat analysis will use Bonferroni-adjusted α = 0.025 for primary outcomes.Ethics and disseminationThe protocol has been approved by the Medical Ethics Committee of the Second People’s Hospital of Liaocheng (Approval Number: [2025] Ethical Review No. (090), date of approval: 31 December 2025). The trial was prospectively registered in the Chinese Clinical Trial Registry (ChiCTR2600117513) on 26 January 2026, and recruitment of the first participant has not yet commenced. All participants will provide written informed consent. Results will be disseminated through peer-reviewed publications and conference presentations regardless of findings.Critical trial registrationhttps://www.chictr.org.cn/, ChiCTR2600117513.
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