Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.

NCT01994967 | Withdrawn Phase 3 DMC

• 1 other identifier: CRT074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.

Conditions

Orthopedic Disorder of Spine

Keywords

Phase III; Noninferiority; Controlled; Double-blind; Randomized; Spinal; Anesthetic; Lower limb

Outcome Measures

Primary Outcomes (2)

• Time of latency to achieve sensitive block of T10.

  The interval of time between the withdrawal of the needle at the end of local anesthetic injection and the absence of response to sensory stimulus in the region corresponding to the T10.

  01 day.

• Duration time of the sensory block of T10.

  Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot.

  01 day.

Secondary Outcomes (5)

• Sensory block intensity.

  02 days.

• Motor block duration.

  02 days.

• Cardiovascular safety.

  02 days.

• Block failure.

  02 days.

• Adverse events.

  02 days.

Study Arms (2)

Levobupivacaine

EXPERIMENTAL

Presentation: injectable solution - ampoule of Levobupivacaine Hydrochloride Indication: production of subarachnoid block (spinal/ spinal anesthesia).

Drug: Levobupivacaine

Bupivacaine

ACTIVE COMPARATOR

Presentation: injectable solution - ampoule of Bupivacaine Hydrochloride Indication: production of subarachnoid block (spinal/ spinal anesthesia).

Drug: Bupivacaine

Interventions

Levobupivacaine DRUG

Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.

Also known as: Levobupivacaine Hydrochloride.

Levobupivacaine

Bupivacaine DRUG

Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.

Also known as: Neocaína ®., Bupivacaine Hydrochloride.

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes;
• Age between 18 and 80 years;
• Risk anesthetic classified as ASA I or ASA II, according to the American Society of Anesthesiology;
• What have indication for spinal orthopedic surgery in the lower limbs;
• Have agreed to participate and signed the informed consent form.

You may not qualify if:

• Absolute or relative contraindications to spinal anesthesia;
• Hypersensitivity or intolerance to local anesthetics or to components of the formula;
• Spinal cord injuries, peripheral neuropathy or other neurological condition that lead to sensitivity and/ or motor function disorder;
• Dementia, mental retardation and others important cognitive changes;
• Obesity with a body mass index ( BMI ) ≥ 35 or difficulty in executing the puncture;
• Anatomical column difficulty in the opinion of the investigator;
• Previous spine surgical intervention;
• Polytrauma;
• Tattoo at the puncture site;
• Alcoholism;
• Abuse of illicit substances;
• Antecedents of severe anaphylactic reactions or Steven - Johnson disease;
• Changes in security checks;
• Pregnancy and lactation;
• Any other condition that in the opinion of the investigator, may lead to increased risk for the patient.

Sponsors & Collaborators

• Cristália Produtos Químicos Farmacêuticos Ltda.: lead
• Newco Trials Pesquisa Científica Ltda: collaborator

Study Sites (5)

IMIP - Instituto de Medicina Integral Prof. Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

Location

Hospital de Base de São José do Rio Preto /SP

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da USP / SP

São Paulo, São Paulo, 05403-010, Brazil

Location

CEMEC - Multidisciplinary Center of Clinical Studies

São Paulo, 09780-000, Brazil

Location

MeSH Terms

Interventions

Levobupivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Onésimo D. Ribeiro Junior, Medic

  CEMEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 26, 2013
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

BR (5)