Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT07209345

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

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, China

Actively Recruiting

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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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