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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • FA+Ropivacaine

    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

  • Ropivacaine

    Drug

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

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Ropivacaine groupActive comparator 1 intervention
Group B: FA+Ropivacaine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The cumulative sufentanil consumption (μg) in PCIA device within 48 hours after craniotomy.

Time frame
within 48 hours after craniotomy

Secondary outcomes

Other outcomes

Sponsors and contacts

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