NCT07209345 Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
| NCT ID | NCT07209345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Post-craniotomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2025-10-15 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-craniotomy pain is common and often associated with poor outcomes. Flurbiprofen axetil (FA) is an injectable NSAID for postoperative analgesia, however, the impact of local FA, remains elusive on post-craniotomy pain. As FA is highly lipophilic by merging into emulsified lipid microspheres, it has a high affinity to the surgical incision and inflammatory tissues to achieve targeted drug therapy and prolonged duration of action. On base of the previous report that local NSAIDs achieved therapeutic tissue concentrations despite a plasma concentration of \<5% of that of systemic administration, a low-dose of FA might be considered a preferential option for local infiltration to avoid anti-platelet related side effects, such as intra-cerebral bleeding. In this study, the investigators attempt to evaluate the clinical effects of pre-emptive scalp infiltration with low-dose FA and ropivacaine for postoperative analgesia after craniotomy.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07209345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Post-craniotomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07209345 currently recruiting?
Yes, NCT07209345 is actively recruiting participants. Contact the research team at 13611326978@163.com for enrollment information.
Where is the NCT07209345 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07209345 clinical trial?
NCT07209345 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 216 participants.