drugset / Trial / NCT07209345

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

NCT07209345

Recruiting 216 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2025-10-15
Primary completion
2026-10-15
Completion
2026-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 150 mg Other
Subject flurbiprofen axetil Other / unclassified 50 mg Other

Indications

No indication recorded.