NCT05624359

Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration

Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration for Post-craniotomy Pain

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	FA plus ropivacaine	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.
DRUG	ropivacaine alone	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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-11-22
• Last updated: 2025-10-06

Locations

1 site across 1 country: China