Postoperative PainNCT05624359
Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration
A study testing FA plus ropivacaine and ropivacaine alone in people with Postoperative Pain, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- FA plus ropivacaine and ropivacaine alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain
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
- Being tested
- FA plus ropivacaine, ropivacaine alone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FA plus ropivacaineDrug
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 aloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: FA plus ropivacaine |
| ropivacaine alone | Active comparator | 15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline Receives: Drug: ropivacaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 48 hours postoperatively
Secondary outcomes (20)
Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy
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.
Measured: at 24 hours postoperatively
Time to first PCIA button press after craniotomy
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.
Measured: after craniotomy
Pain NRS scores at 2 hours after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 2 hours after craniotomy
Pain NRS scores at 4 hours after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 4 hours after craniotomy
Pain NRS scores at 12 hours after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 12 hours after craniotomy
Pain NRS scores at 24 hours after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 24 hours after craniotomy
Pain NRS scores at 48 hours after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 48 hours after craniotomy
Pain NRS scores at 1 mon after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 1 mon after craniotomy
Pain NRS scores at 3 mons after craniotomy
0 indicates no pain and 10 indicates the worst pain imaginable
Measured: at 3 mons after craniotomy
The time to first prescription of OC/APAP after craniotomy
In the ward, if a patient scores > 4 in pain NRS after receiving a maximum dose of 2 mL per hour from PCIA device, an oral supplementary tablet of oxycodone (OC)/acetaminophen (APAP) (5/325 mg; by MallinckrodtInc, USA) will be prescribed as a rescue analgesic at an interval of at least 6 hours.
Measured: up to 48 hours after craniotmy
Hospital duration after craniotomy
The duration from end of surgery to discharge from hospital
Measured: From surgery day until the discharge date from hospital, assessed up to one week
WHOQOL-BREF score
It is a questionnaire consisting of social relationships, physical health, psychological health, environment, overall QoL and general health. The mean score of each domain ranges between 4 and 20. A higher score indicates a better QoL
Measured: at 1month after craniotomy
WHOQOL-BREF score
It is a questionnaire consisting of social relationships, physical health, psychological health, environment, overall QoL and general health. The mean score of each domain ranges between 4 and 20. A higher score indicates a better QoL
Measured: at 3 months after craniotomy
PONV scores
It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
Measured: at 24 hours after surgery
PONV scores
It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
Measured: at 48 hours after surgery
Wound healing score
It is rated as excellent, good and suboptimal
Measured: at 1 month after craniotomy
Wound healing score
It is rated as excellent, good and suboptimal
Measured: at 3 months after craniotomy
Patient and Observer Scar Assessment Scale
It consists of 2 numeric scales regarding the observer component (6 items) and the patient component (6 items). All included items are scored on the same 10-point scale. And a higher score represents a poorer scar quality.
Measured: at 1 month after craniotomy
Patient and Observer Scar Assessment Scale
It consists of 2 numeric scales regarding the observer component (6 items) and the patient component (6 items). All included items are scored on the same 10-point scale. And a higher score represents a poorer scar quality.
Measured: at 3 months after craniotomy
The occurrence of other AEs
Other AEs include cerebral hematoma, respiratory depression, gastrointestinal ulcerations and perforation, renal risks, coagulation dysfunction, allergic reaction and wound infection, oozing, hemorrhage, burning sensation and mild pruritus
Measured: throughout both the treatment and follow-up periods (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Nov 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Why it stopped: One case with postoperative subdural hematoma was reported to the Institutional Review Board and DMC. This study was suspended. The association with study interventions remained to be explored.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624359
- Sponsor's protocol ID
- 2018-034-02-10
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2022
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain
- ClinicalTrials.gov ID
- NCT05624359
- Acronym / sponsor ID
- 2018-034-02-10
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: One case with postoperative subdural hematoma was reported to the Institutional Review Board and DMC. This study was suspended. The association with study interventions remained to be explored.
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine plus FA | Experimental | Drug: FA plus ropivacaine5 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 |
| ropivacaine alone | Active comparator | Drug: ropivacaine alone15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FA plus ropivacaineTh 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. | Drug | ropivacaine plus FA |
| ropivacaine aloneThe 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. | Drug | ropivacaine alone |
Primary outcome
Total consumption of sufentanil with PCIA device at 48 hours postoperatively.
Time frame: 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.
20 secondary outcomes
Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy
Time frame: at 24 hours postoperatively
Time to first PCIA button press after craniotomy
Time frame: after craniotomy
Pain NRS scores at 2 hours after craniotomy
Time frame: at 2 hours after craniotomy
Pain NRS scores at 4 hours after craniotomy
Time frame: at 4 hours after craniotomy
Pain NRS scores at 12 hours after craniotomy
Time frame: at 12 hours after craniotomy
Pain NRS scores at 24 hours after craniotomy
Time frame: at 24 hours after craniotomy
Pain NRS scores at 48 hours after craniotomy
Time frame: at 48 hours after craniotomy
Pain NRS scores at 1 mon after craniotomy
Time frame: at 1 mon after craniotomy
Pain NRS scores at 3 mons after craniotomy
Time frame: at 3 mons after craniotomy
The time to first prescription of OC/APAP after craniotomy
Time frame: up to 48 hours after craniotmy
Hospital duration after craniotomy
Time frame: From surgery day until the discharge date from hospital, assessed up to one week
WHOQOL-BREF score
Time frame: at 1month after craniotomy
WHOQOL-BREF score
Time frame: at 3 months after craniotomy
PONV scores
Time frame: at 24 hours after surgery
PONV scores
Time frame: at 48 hours after surgery
Wound healing score
Time frame: at 1 month after craniotomy
Wound healing score
Time frame: at 3 months after craniotomy
Patient and Observer Scar Assessment Scale
Time frame: at 1 month after craniotomy
Patient and Observer Scar Assessment Scale
Time frame: at 3 months after craniotomy
The occurrence of other AEs
Time frame: throughout both the treatment and follow-up periods (up to 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FA plus ropivacaine and ropivacaine alone in people with Postoperative Pain, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total consumption of sufentanil with PCIA device at 48 hours postoperatively. (time frame: at 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.