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

Recruiting now · Not applicable

Conditions studied: Post-craniotomy, Pain

In brief

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.

Key facts

Study ID

NCT07209345

Run by

Beijing Tiantan Hospital

People needed

216

Starts

2025-10-15

Expected to finish

2026-10-15

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• Glasgow Coma Scale <15;
• Unable to use the PCIA device or comprehend the pain NRS;
• History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery;
• Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease;
• History of allergy to any drug used in the study.

Where it is running

• Beijing Tiantan Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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