Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration (NCT05624359) | Clinical Trial Compass
SuspendedNot Applicable
Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration
Stopped: One case with postoperative subdural hematoma was reported to the Institutional Review Board and DMC. This study was suspended. The association with study interventions remained to be explored.
China216 participantsStarted 2023-11-01
Plain-language summary
Post-craniotomy pain remains a major challenge in patient care following neurosurgery.Flurbiprofen axetil (FA), as an injectable nonselective cyclooxygenase inhibitor, is a widely prescribed NSAID for postoperative 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, thus providing a basis for its local use to achieve efficacy and safety comparable to or greater than systemic administration. In this study, we attempt to evaluate the clinical effects of FA as an adjunct to ropivacaine in pre-emptive scalp infiltration to prevent or reduce pain after craniotomy.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age minimum 18 years;
. ASA physical status of I - II;
. Body mass index (BMI) of 15 - 30;
. Scheduled for supratentorial 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
. History of opioid dependence, chronic headache or intake of any drugs with known analgesic properties within the 24 hours before surgery;
. History of craniotomy or scalp infection;
. 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;