Orthopedic Disorder of SpinePhase 3NCT01994967
Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.
A Phase 3 study testing Levobupivacaine and Bupivacaine in people with Orthopedic Disorder of Spine, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 5 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Disorder of Spine
- What is being tested?
- Levobupivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesBrazil
- Study dates
- Nov 2016to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Participation in a clinical study in the 12 months preceding this inclusion;
- Pregnancy and lactation;
- Any other condition that in the opinion of the investigator, may lead to increased risk for the patient.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093
IMIP - Instituto de Medicina Integral Prof. Fernando Figueira
Recife, Pernambuco, 50070-550
Hospital de Base de São José do Rio Preto /SP
São José do Rio Preto, São Paulo, 15090-000
Hospital das Clínicas da Faculdade de Medicina da USP / SP
São Paulo, São Paulo, 05403-010
CEMEC - Multidisciplinary Center of Clinical Studies
São Paulo, 09780-000
About this study
Official title: Study Phase III to Evaluate the Noninferiority of Heavy Levobupivacaine 50% Enantiomeric Excess (Levobupivacaine S75:R25) Compared to Racemic Heavy Bupivacaine (Bupivacaine S50:R50) in Spinal Anesthesia for Lower Limb Orthopedic Procedures
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.
Read the detailed description
Objectives:
Primary:
- Evaluation of latency to sensory block of T10.
- Evaluation of the duration of sensory block.
Secondary:
- Evaluation of the motor block degree.
- Evaluation of motor block duration.
- Evaluation of cardiovascular safety.
- Block failure.
- Observation of adverse events.
Study Plan:
- Estimated 120 research participants;
- Aged between 18 - 80 in both gender;
- Drug Intervention: 01 day
Evaluations during Trial:
- Classification of anesthetic risk: Class I to VI by the American Society of Anesthesiologists(ASA);
- Identification of the Anesthetic Failure;
- Latency time for sensory block at T10;
- Duration of sensory block and motor block;
- Bromage scale;
- Cardiovascular safety;
Retention of Records:
The investigator shall retain all documentation of the study over a period of at least five years from the end of the study. The Sponsor or its designee will provide a list of all documentation which should be kept by the Investigator.
Monitoring:
All aspects of the study will be carefully monitored by Cristália Pharmaceutical Chemicals Ltda. or designated representative of it (Clinical Research Organization - CRO) for evaluations related to good clinical practice and applicable local regulations.
Case Report Forms. The Monitor will be available if the investigator, or other person of his team, needs information and guidance.
The Monitor of the study should have permanent access to all documentation and it is his obligation to ensure that the Case Report Forms are complete and completed correctly, as well as checking if the data are described according to the source documents, in order to eliminate interferences that may compromise the accuracy of the data generated in the clinical trial.
Audit and Inspections:
Authorized representatives of the Sponsor or designees, regulatory authority or the Ethics Committee of the institution may conduct audits or inspections during or after the study conclusion.
Collecting Data:
The information corresponding to the data of interest from the study will be collected and recorded in Case Report forms provided by Sponsor, and filled from the information contained in the source documents.
Documents are considered sources for study: medical records used by the professional at the time of the visits, diagnostic tests or image.
Informed Consent of Trial:
The Principal Investigator will ensure that the research participant receive verbally and in writing all relevant information about the nature, purpose, the test drug, the possible risks and benefits of the study.
Research participants will be notified that they are free to discontinue the study at any time. That they will have the opportunity to ask questions and to have sufficient time to consider the information received.
Formation of the database:
The database of the study will be assembled with the data from the Case Report Forms. Doubts and discrepancies will generate questions (queries) written to the Principal Investigator.
- Conditions
- Orthopedic Disorder of Spine
- Being tested
- Levobupivacaine, Bupivacaine
- Keywords
- Phase III, Noninferiority, Controlled, Double-blind, Randomized, Spinal, Anesthetic, Lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Levobupivacaine Hydrochloride.
Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
BupivacaineDrug
Also called Neocaína ®., Bupivacaine Hydrochloride.
Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Experimental | Presentation: injectable solution - ampoule of Levobupivacaine Hydrochloride
Indication: production of subarachnoid block (spinal/ spinal anesthesia). Receives: Drug: Levobupivacaine |
| Bupivacaine | Active comparator | Presentation: injectable solution - ampoule of Bupivacaine Hydrochloride
Indication: production of subarachnoid block (spinal/ spinal anesthesia). Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 01 day.
Secondary outcomes (5)
Sensory block intensity.
Ability of the patient to move their lower limbs, assessed by Bromage scale.
Measured: 02 days.
Motor block duration.
Time interval between the end of anesthetic injection and the return to 0 score in modified Bromage scale.
Measured: 02 days.
Cardiovascular safety.
Incidence and severity of hemodynamic (BP and HR) and respiratory (SpO2) alterations.
Measured: 02 days.
Block failure.
To evaluate the absence of signs of analgesia or motor block for at least 20 minutes after anesthetic injection in the sensitive region studied.
Measured: 02 days.
Adverse events.
To evaluate the occurrence of adverse events regarding the frequency, duration, severity and causal relationship with the study medication.
Measured: 02 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionJan 2017
Why it stopped: Another regulatory way was defined.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Disorder of SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Newco Trials Pesquisa Científica Ltda
- Responsible party
- Sponsor
- Investigators
- Onésimo D. Ribeiro Junior, Medic, Principal investigator, CEMEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994967
- Sponsor's protocol ID
- CRT074
- Status last verified
- Jul 2017
- First submitted
- 30 Oct 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Phase III to Evaluate the Noninferiority of Heavy Levobupivacaine 50% Enantiomeric Excess (Levobupivacaine S75:R25) Compared to Racemic Heavy Bupivacaine (Bupivacaine S50:R50) in Spinal Anesthesia for Lower Limb Orthopedic Procedures
- ClinicalTrials.gov ID
- NCT01994967
- Acronym / sponsor ID
- CRT074
- Conditions
- Orthopedic Disorder of Spine
- Keywords
- Phase III, Noninferiority, Controlled, Double-blind, Randomized, Spinal, Anesthetic, Lower limb
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Another regulatory way was defined.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Newco Trials Pesquisa Científica Ltda
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Primary:
- Evaluation of latency to sensory block of T10.
- Evaluation of the duration of sensory block.
Secondary:
- Evaluation of the motor block degree.
- Evaluation of motor block duration.
- Evaluation of cardiovascular safety.
- Block failure.
- Observation of adverse events.
Study Plan:
- Estimated 120 research participants;
- Aged between 18 - 80 in both gender;
- Drug Intervention: 01 day
Evaluations during Trial:
- Classification of anesthetic risk: Class I to VI by the American Society of Anesthesiologists(ASA);
- Identification of the Anesthetic Failure;
- Latency time for sensory block at T10;
- Duration of sensory block and motor block;
- Bromage scale;
- Cardiovascular safety;
Retention of Records:
The investigator shall retain all documentation of the study over a period of at least five years from the end of the study. The Sponsor or its designee will provide a list of all documentation which should be kept by the Investigator.
Monitoring:
All aspects of the study will be carefully monitored by Cristália Pharmaceutical Chemicals Ltda. or designated representative of it (Clinical Research Organization - CRO) for evaluations related to good clinical practice and applicable local regulations.
Case Report Forms. The Monitor will be available if the investigator, or other person of his team, needs information and guidance.
The Monitor of the study should have permanent access to all documentation and it is his obligation to ensure that the Case Report Forms are complete and completed correctly, as well as checking if the data are described according to the source documents, in order to eliminate interferences that may compromise the accuracy of the data generated in the clinical trial.
Audit and Inspections:
Authorized representatives of the Sponsor or designees, regulatory authority or the Ethics Committee of the institution may conduct audits or inspections during or after the study conclusion.
Collecting Data:
The information corresponding to the data of interest from the study will be collected and recorded in Case Report forms provided by Sponsor, and filled from the information contained in the source documents.
Documents are considered sources for study: medical records used by the professional at the time of the visits, diagnostic tests or image.
Informed Consent of Trial:
The Principal Investigator will ensure that the research participant receive verbally and in writing all relevant information about the nature, purpose, the test drug, the possible risks and benefits of the study.
Research participants will be notified that they are free to discontinue the study at any time. That they will have the opportunity to ask questions and to have sufficient time to consider the information received.
Formation of the database:
The database of the study will be assembled with the data from the Case Report Forms. Doubts and discrepancies will generate questions (queries) written to the Principal Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Experimental | Drug: LevobupivacainePresentation: injectable solution - ampoule of Levobupivacaine Hydrochloride Indication: production of subarachnoid block (spinal/ spinal anesthesia). |
| Bupivacaine | Active comparator | Drug: BupivacainePresentation: injectable solution - ampoule of Bupivacaine Hydrochloride Indication: production of subarachnoid block (spinal/ spinal anesthesia). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineAlso: Levobupivacaine Hydrochloride.Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via. | Drug | Levobupivacaine |
| BupivacaineAlso: Neocaína ®., Bupivacaine Hydrochloride.Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via. | Drug | Bupivacaine |
Primary outcome
Time of latency to achieve sensitive block of T10.
Time frame: 01 day.
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.
Duration time of the sensory block of T10.
Time frame: 01 day.
Duration of anesthesia as for the sensory aspect through a needle stimulus in the anterior side of the foot.
5 secondary outcomes
Sensory block intensity.
Time frame: 02 days.
Motor block duration.
Time frame: 02 days.
Cardiovascular safety.
Time frame: 02 days.
Block failure.
Time frame: 02 days.
Adverse events.
Time frame: 02 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onésimo D. Ribeiro Junior, Medic principal investigator
CEMEC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levobupivacaine and Bupivacaine in people with Orthopedic Disorder of Spine, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of latency to achieve sensitive block of T10. (time frame: 01 day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.