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NCT Number: NCT07209345

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

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.

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Key information

Conditions

Post-craniotomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

FA+Ropivacaine

Drug

0.5 mL FA (50 mg; 5 mL; by Beijing Taide Pharmaceutical Co., Ltd) and 15 mL of 1% ropivacaine (Nai Le Pin 10mg/mL; by AstraZeneca AB, Sweden) diluted to a total volume of 30 mL in normal saline

Ropivacaine

Drug

15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline

Primary outcomes

  1. The cumulative sufentanil consumption (μg) in PCIA device within 48 hours after craniotomy.

    Time frame: within 48 hours after craniotomy

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo, MD

CONTACT

[email protected]

+86 5997 6660

Wei Zhang, MD

CONTACT

[email protected]

+86 5997 6660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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