Pain, Post-craniotomy
Conditions
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.
Interventions
DRUGFA+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
DRUGRopivacaine
15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative sufentanil consumption (μg) in PCIA device within 48 hours after craniotomy. | within 48 hours after craniotomy |
Countries
China
Contacts
Primary ContactFang Luo, MD
Backup ContactWei Zhang, MD
Outcome results
None listed