NCT03883763

Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery

Non-inferiority Study of Hyperbaric Novabupi® (Bupivacaine S75: R25) Compared to Hyperbaric Neocaine® (Bupivacaine S50: R50) in Spinal Anesthesia in Lower Limbs Vascular Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery. The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).

Conditions

• Spinal Anesthesia
• Vascular Surgery

Interventions

Type	Name	Description
DRUG	bupivacaine S75:R25 plus 8% glucose	Spinal anesthesia, 20 mg
DRUG	bupivacaine S50:R50 plus 8% glucose	Spinal anesthesia, 20 mg

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-04-30
• Completion: 2023-11-30
• First posted: 2019-03-21
• Last updated: 2023-02-08

Locations

1 site across 1 country: Brazil