Actively Recruiting
Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
Led by Beijing Tiantan Hospital · Updated on 2025-11-17
216
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-64 years
- ASA physical status of I - II
- Scheduled for craniotomy under general anesthesia
- Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy
You will not qualify if you...
- Glasgow Coma Scale less than 15
- Unable to use the PCIA device or understand the pain numeric rating scale
- History of opioid dependence, chronic headache, or use of analgesic drugs within 24 hours before surgery
- Contraindications to flurbiprofen axetil (such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure, ischemic heart disease)
- History of allergy to any study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, China
Actively Recruiting
Research Team
F
Fang Luo, MD
CONTACT
W
Wei Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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