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

NCT07209345 | Recruiting DMC

• 1 other identifier: KY-2018-034-02-11
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-craniotomy; Pain

Outcome Measures

Primary Outcomes (1)

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

  within 48 hours after craniotomy

Study Arms (2)

Ropivacaine group

ACTIVE COMPARATOR

0.5% ropivacaine was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder at about 30 min before surgical incision

Drug: Ropivacaine

FA+Ropivacaine group

EXPERIMENTAL

5mg FA and 0.5% ropivacaine was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder at about 30 min before surgical incision

Drug: FA+Ropivacaine

Interventions

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

FA+Ropivacaine group

Ropivacaine DRUG

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

Ropivacaine group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Fang Luo, MD

CONTACT

+86 5997 6660; 13611326978@163.com

Wei Zhang, MD

CONTACT

+86 5997 6660; 13810045210@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)