Pre-emptive scalp infiltration with low-dose flurbiprofen plus ropivacaine for post-craniotomy pain

Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy

This trial will test whether injecting low-dose flurbiprofen together with ropivacaine into the scalp before craniotomy reduces postoperative pain in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07209345 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo, MD

Conditions Post-craniotomy; Pain