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

NCT ID: NCT07209345

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ropivacaine group

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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

FA+Ropivacaine group

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

Group Type: EXPERIMENTAL

FA+Ropivacaine

Intervention Type: 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

Interventions

FA+Ropivacaine

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

Intervention Type: DRUG

Ropivacaine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-64 years;

2. ASA physical status of I - II;

3. Scheduled for craniotomy under general anesthesia;

4. Anticipated tracheal extubation, recovery of consciousness and orientation within 2 hours after craniotomy.

Exclusion Criteria

1. Glasgow Coma Scale <15;

2. Unable to use the PCIA device or comprehend the pain NRS;

3. History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery;

4. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease;

5. History of allergy to any drug used in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang Luo, MD

Role: CONTACT

13611326978@163.com

+86 5997 6660

Wei Zhang, MD

Role: CONTACT

13810045210@163.com

+86 5997 6660

Facility Contacts

Fang Luo, MD

Role: primary

13611326978@163.com

+86 5997 6660

Other Identifiers

KY-2018-034-02-11

Identifier Type: -

Identifier Source: org_study_id