Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: ropivacaine alone; Drug: FA plus ropivacaine

• Registration Number: NCT05624359
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-22
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine alone	ropivacaine alone	15 mL of 1% ropivacaine diluted to a total volume of 30 mL in normal saline
ropivacaine plus FA	FA plus ropivacaine	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

Primary Outcome Measures

Name	Time	Method
Total consumption of sufentanil with PCIA device at 48 hours postoperatively.	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.

Secondary Outcome Measures

Name	Time	Method
Pain NRS scores at 1 mon after craniotomy	at 1 mon after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
Total consumption of sufentanil with PCIA pump at 24 hours after craniotomy	at 24 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.
Pain NRS scores at 4 hours after craniotomy	at 4 hours after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
Pain NRS scores at 48 hours after craniotomy	at 48 hours after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
PONV scores	at 48 hours after surgery	It is rated as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting
Pain NRS scores at 12 hours after craniotomy	at 12 hours after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
Pain NRS scores at 24 hours after craniotomy	at 24 hours after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
Pain NRS scores at 2 hours after craniotomy	at 2 hours after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
Pain NRS scores at 3 mons after craniotomy	at 3 mons after craniotomy	0 indicates no pain and 10 indicates the worst pain imaginable
Hospital duration after craniotomy	From surgery day until the discharge date from hospital, assessed up to one week	The duration from end of surgery to discharge from hospital
Wound healing score	at 3 months after craniotomy	It is rated as excellent, good and suboptimal
Time to first PCIA button press after craniotomy	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.
WHOQOL-BREF score	at 3 months after craniotomy	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
Patient and Observer Scar Assessment Scale	at 3 months after craniotomy	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.
The occurrence of other AEs	throughout both the treatment and follow-up periods (up to 3 months)	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
The time to first prescription of OC/APAP after craniotomy	up to 48 hours after craniotmy	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China