Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

NCT05624359 | Suspended

• 1 other identifier: 2018-034-02-10
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total consumption of sufentanil with PCIA device at 48 hours postoperatively.

  A postoperative Patient Controlled Intravenous Analgesia (PCIA) pump containing sufentanil 200μg in 100 mL saline will be administered from admission to the PACU until postoperative 48 hours. The PCIA pump will be set for 0.5 mL bolus doses with a lockout time of 15 min without initial dose or continuous infusion. The maximum dose will be limited to 2 mL (sufentanil 4 μg) per hour.

  at 48 hours postoperatively

Secondary Outcomes (20)

• Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy

  at 24 hours postoperatively

• Time to first PCIA button press after craniotomy

  after craniotomy

• Pain NRS scores at 2 hours after craniotomy

  at 2 hours after craniotomy

• Pain NRS scores at 4 hours after craniotomy

  at 4 hours after craniotomy

• Pain NRS scores at 12 hours after craniotomy

  at 12 hours after craniotomy

Study Arms (2)

ropivacaine plus FA

EXPERIMENTAL

5 mL FA (50 mg; 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: FA plus ropivacaine

ropivacaine alone

ACTIVE COMPARATOR

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

Drug: ropivacaine alone

Interventions

FA plus ropivacaine DRUG

Th group will receive 0.17% FA and 0.5% ropivacaine for pre-emptive scalp infiltration at about 30 min before surgical incision. The assigned solution was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder, using a 22-gauge needle introduced throughout the entire thickness of the scalp at a 45° angle.

ropivacaine plus FA

ropivacaine alone DRUG

The ropivacaine alone group will receive 0.5% ropivacaine alone for pre-emptive scalp infiltration at about 30 min before surgical incision. The assigned solution was injected along the planned surgical incision and pin fixation sites of the Mayfield head holder, using a 22-gauge needle introduced throughout the entire thickness of the scalp at a 45° angle.

ropivacaine alone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Pregnancy and breastfeeding.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ProFessor

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 22, 2022
• Study Start: November 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)