Pre-emptive scalp infiltration with low-dose flurbiprofen plus ropivacaine for post-craniotomy pain
Official title: Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
Run by Beijing Tiantan Hospital · NCT07209345 · Data updated 2026-11-12
This trial will test whether injecting low-dose flurbiprofen together with ropivacaine into the scalp before craniotomy reduces postoperative pain in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 216 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | October 15, 2026 |
| Study ends | October 15, 2026 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT07209345 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–64 with ASA physical status I–II undergoing craniotomy who are expected to awaken and be extubated within two hours and have no contraindications to flurbiprofen.
✕Probably not a fit
Patients with coagulation disorders, active gastrointestinal ulcers, significant cardiac or renal disease, allergy to study drugs, opioid dependence, chronic headache, or inability to use or understand the PCIA device are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–64 scheduled for craniotomy receive pre-emptive scalp infiltration either with low-dose flurbiprofen axetil plus ropivacaine or with ropivacaine alone. Postoperative analgesia is managed with standardized protocols including patient-controlled intravenous analgesia and pain measured by numeric rating scales. The comparison aims to determine if adding local, low-dose flurbiprofen provides longer or better pain control and reduces opioid consumption while keeping systemic NSAID exposure low. Patients with contraindications to flurbiprofen, recent analgesic use, or inability to use PCIA are excluded for safety and data integrity.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative pain and opioid use after craniotomy while limiting systemic NSAID exposure.
How similar studies have gone: Prior reports show local NSAIDs can achieve therapeutic tissue concentrations with low plasma levels, but the specific use of flurbiprofen axetil for scalp infiltration after craniotomy remains limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-64 years; 2. ASA physical status of I - II; 3. Scheduled for craniotomy under general anesthesia; 4. Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy. Exclusion Criteria: 1. Glasgow Coma Scale \<15; 2. Unable to use the PCIA device or comprehend the pain NRS; 3. History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery; 4. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease; 5. History of allergy to any drug used in the study.
Where it's running
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Beijing Tiantan Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Fang Luo, MD
- Email: 13611326978@163.com
- Phone: +86 5997 6660
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.