Disorder of KneePhase 4levobupiNCT01881087

Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy

A Phase 4 study testing Hyperbaric Levobupivacaine 0.75% in people with Disorder of Knee and Anesthesia, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Disorder of Knee, Anesthesia
What is being tested?: Hyperbaric Levobupivacaine 0.75%
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteColombia
Study dates: Jun 2006to Jul 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)

Who cannot join

Cardiac or pulmonary disease
Antiplatelet or anticoagulant drugs use during 7 days before surgery
History of coagulative disorders
Bilateral procedures

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Fundación Valle del Lili
Cali, Valle del Cauca Department, 76001000

Other trials in Colombia

About this study

Official title: Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy: A Double Blind, Randomized Clinical Trial Comparing Three Low Doses

Read the detailed description

Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus position maintained for 5 min after injection.

An independent observer will evaluate motor (modified Bromage scale) and sensory (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and presence of adverse events immediately after return to supine, at the end of surgery and each 10 min from admission to PACU until home discharge conditions.

Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.

Conditions: Disorder of Knee, Anesthesia
Being tested: Hyperbaric Levobupivacaine 0.75%
Keywords: Knee Arthroscopy, Levobupivacaine, Spinal Anesthesia, Motor Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperbaric Levobupivacaine 0.75%Drug
Also called Bupinest 0.75% Pesado
Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.

Study groups in NCT01881087
Study group	Role	What they receive
Levo-7.5 mg	Experimental	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. Receives: Drug: Hyperbaric Levobupivacaine 0.75%
Levo-9.37	Experimental	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. Receives: Drug: Hyperbaric Levobupivacaine 0.75%
Levo-11.25	Active comparator	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. Receives: Drug: Hyperbaric Levobupivacaine 0.75%

What is being measured

The primary outcome is the main question the study is designed to answer.

Probability of Motor Block
Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%
Measured: 200 minutes

Secondary outcomes (1)

Failed Spinal Block Rate
Failed Spinal Block Rate for each treatment group
Measured: 15 minutes after dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Jul 2010

First posted19 Jun 2013 (estimated)
Study startJun 2006
Primary completionDec 2009
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Disorder of KneeStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01881087
Sponsor's protocol ID: LevoBupi-003
Acronym: levobupi
Status last verified: Apr 2017
First submitted: 16 Jun 2013
Last updated: 12 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD is available if DB is formally requested to the Clinical Research Center of the Fundación Valle del Lili (Info: +57 3319090 Ext 4124. http://www.institutodeinvestigaciones.org/)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Disorder of Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy: A Double Blind, Randomized Clinical Trial Comparing Three Low Doses
ClinicalTrials.gov ID: NCT01881087
Acronym / sponsor ID: levobupi / LevoBupi-003
Conditions: Disorder of Knee, Anesthesia
Keywords: Knee Arthroscopy, Levobupivacaine, Spinal Anesthesia, Motor Block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Fundacion Clinica Valle del LiliUniversity, hospital or other
Study start: Jun 2006
Primary completion: Dec 2009 (actual)
Study completion: Jul 2010 (actual)
First posted: 19 Jun 2013 (estimated)
Results: Posted 12 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Levo-7.5 mg	Experimental	Drug: Hyperbaric Levobupivacaine 0.75%Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Levo-9.37	Experimental	Drug: Hyperbaric Levobupivacaine 0.75%Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Levo-11.25	Active comparator	Drug: Hyperbaric Levobupivacaine 0.75%Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)

Key exclusion criteria (4 listed)

Cardiac or pulmonary disease
Antiplatelet or anticoagulant drugs use during 7 days before surgery
History of coagulative disorders
Bilateral procedures

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
Hyperbaric Levobupivacaine 0.75%Also: Bupinest 0.75% PesadoEach 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.	Drug	Levo-11.25, Levo-7.5 mg, Levo-9.37

Primary outcome

Probability of Motor Block
Time frame: 200 minutes
Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%

1 secondary outcome

Failed Spinal Block Rate
Time frame: 15 minutes after dose

Results and safety

Results posted to the registry on 12 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levo-7.5 mg	60	59
Levo-9.37	61	61
Levo-11.25	62	60

Primary outcome: Probability of Motor Block

Time frame: 200 minutes. Number. Unit: percentage of motor block

Measure	Levo-7.5 mg n = 59	Levo-9.37 n = 61	Levo-11.25 n = 60
Value	5	20	27

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levo-7.5 mg	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Levo-9.37	0 of 61 (0%)	0 of 61 (0%)	0 of 61
Levo-11.25	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
http://apps.elsevier.es/watermark/ctl\_servlet?\_f=10\&pident\_articulo=90150010\&pident\_usuario=0\&pcontactid=\&pident\_revista=341\&ty=7\&accion=L\&origen=reuma%20\&web=http://www.revcolanest.com.co\&lan=es\&fichero=341v38n04a90150010pdf001.pdfLink provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available if DB is formally requested to the Clinical Research Center of the Fundación Valle del Lili (Info: +57 3319090 Ext 4124. http://www.institutodeinvestigaciones.org/)

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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.

Fredy J Ariza, MD., MSc. principal investigator

Fundacion Clinica Valle del Lili

Marisol Badiel, MD., MSc. study chair

Unidad de Investigaciones Clínicas, Fundación Valle del Lili

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hyperbaric Levobupivacaine 0.75% in people with Disorder of Knee and Anesthesia, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.

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 1 inclusion and 4 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: finished, as of the sponsor's last update on 12 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 1 site in Colombia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Probability of Motor Block (time frame: 200 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01881087.

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 12 Jul 2017.