Clinical trial NCT05624359: Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration
Official title: Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
timeFrame: at 48 hours postoperatively
Secondary outcomes:
measure: Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy
timeFrame: at 24 hours postoperatively
measure: Time to first PCIA button press after craniotomy
timeFrame: after craniotomy
measure: Pain NRS scores at 2 hours after craniotomy
timeFrame: at 2 hours after craniotomy
measure: Pain NRS scores at 4 hours after craniotomy
timeFrame: at 4 hours after craniotomy
measure: Pain NRS scores at 12 hours after craniotomy
timeFrame: at 12 hours after craniotomy
measure: Pain NRS scores at 24 hours after craniotomy
timeFrame: at 24 hours after craniotomy
measure: Pain NRS scores at 48 hours after craniotomy
timeFrame: at 48 hours after craniotomy
measure: Pain NRS scores at 1 mon after craniotomy
timeFrame: at 1 mon after craniotomy
measure: Pain NRS scores at 3 mons after craniotomy
timeFrame: at 3 mons after craniotomy
measure: The time to first prescription of OC/APAP after craniotomy
timeFrame: up to 48 hours after craniotmy
measure: Hospital duration after craniotomy
timeFrame: From surgery day until the discharge date from hospital, assessed up to one week
measure: WHOQOL-BREF score
timeFrame: at 1month after craniotomy
measure: WHOQOL-BREF score
timeFrame: at 3 months after craniotomy
measure: PONV scores
timeFrame: at 24 hours after surgery
measure: PONV scores
timeFrame: at 48 hours after surgery
measure: Wound healing score
timeFrame: at 1 month after craniotomy
measure: Wound healing score
timeFrame: at 3 months after craniotomy
measure: Patient and Observer Scar Assessment Scale
timeFrame: at 1 month after craniotomy
measure: Patient and Observer Scar Assessment Scale
timeFrame: at 3 months after craniotomy
measure: The occurrence of other AEs
timeFrame: throughout both the treatment and follow-up periods (up to 3 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: