Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FA+Ropivacaine, Ropivacaine.
- Who it may be relevant to
- Registry conditions: Post-craniotomy, Pain. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug 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 - Drug Ropivacaine
15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline
Primary outcome measures
- The cumulative sufentanil consumption (μg) in PCIA device within 48 hours after craniotomy. [Time frame: within 48 hours after craniotomy]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT07209345 · KY-2018-034-02-11