Using Flurbiprofen Axetil to Reduce Pain After Brain Surgery

Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain

This study is testing if adding flurbiprofen axetil to the pain relief medicine ropivacaine can help reduce pain after brain surgery for patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05624359 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of flurbiprofen axetil (FA) as an adjunct to ropivacaine for preventing postoperative pain in patients undergoing craniotomy. FA is a nonselective cyclooxygenase inhibitor that is injected locally to target surgical incisions and inflammatory tissues, potentially offering better pain relief than systemic administration. The study compares the pain management outcomes of patients receiving FA combined with ropivacaine versus those receiving ropivacaine alone. The goal is to determine if this combination can enhance pain control after surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for supratentorial craniotomy with a BMI of 15-30.

Not a fit: Patients with a Glasgow Coma Scale score below 15 or those with a history of opioid dependence or contraindications to flurbiprofen axetil may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pain management for patients recovering from craniotomy.

How similar studies have performed: While the specific combination of FA and ropivacaine is novel, similar approaches using local anesthetics for postoperative pain management have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Age minimum 18 years;
2. ASA physical status of I - II;
3. Body mass index (BMI) of 15 - 30;
4. Scheduled for supratentorial craniotomy under general anesthesia;
5. 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. History of craniotomy or scalp infection;
5. Any contraindication to flurbiprofen axetil, such as gastrointestinal ulcer, coagulation disorders, renal dysfunction, heart failure and ischemic heart disease;
6. History of allergy to any drug used in the study;
7. Pregnancy and breastfeeding.

Where this trial is running

Beijing

• Beijing Tiantan Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Fang Luo, Doctor

Conditions: Postoperative Pain