study to the evaluate non-inferiority Compared two local anesthetic for orthopedic procedures on the lower limbs

Phase 3

• Conditions: S90-S99; broken leg, foot and / or ankle injury in the ankle or foot.

• Registration Number: RBR-39z9pb
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients who agree to participate in the study and signed the consent form, both sexes, aged between 18 and 80 years inclusive, ASA I or ASA II with indication for spinal anesthesia for orthopedic surgery of the lower limbs

Exclusion Criteria

Absolute or relative contraindications to spinal anesthesia ; intolerance or hypersensitivity to local anesthetics or components of the formula , spinal cord injuries , peripheral neuropathy or other neurological disorders that lead to disturbances of sensation and / or motor function , dementia , mental retardation and other important cognitive changes ; obesity with body mass index ? 35 or difficulty in executing the puncture ; anatomical difficulty column in the Investigator's opinion , previous surgery of the spine ; polytrauma ; tattoo at the puncture site , alcoholism , substance abuse , history severe Stevens- Johnson anaphylactic reactions, changes in safety tests ( INR > 1.4 , platelet count < 100,000 mm3 , blood glucose > 200mg/dl , bradyarrhythmias , heart block , frequent premature ventricular beats or saved evident on ECG ) ; participation in any clinical trial within the 12 months preceding their inclusion , pregnancy or lactation, any other condition that , in the Investigator's opinion , may lead to increased risk to the patient.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
atency time evaluation (waiting) for sensory block by the time interval spent between the withdrawal of the needle at the end of the local anesthetic injection and the absence of response to sensory impulse.

Secondary Outcome Measures

Name	Time	Method
Motor block degree evaluation by modified Bromage scale;<br>Motor block duration measured by the time interval between the withdrawal of the needle after the puncture and the return to level 0 in the modified Bromage scale;<br>Cardiovascular safety evidenced by the incidence and severity of changes<br>Blood pressure and heart rate measurements automatically by the device;<br>Anesthesia failure: classification will be evaluated in total failure or partial failure identified by the absence or presence of sensory and motor aspects);<br>Presence of adverse events identified by means of unexpected effects.