Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy (levobupi)

April 19, 2017 updated by: Fredy Ariza, Fundacion Clinica Valle del Lili

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle del Cauca
      • Cali, Valle del Cauca, Colombia, 76001000
        • Fundacion Valle del Lili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levo-7.5 mg
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Drug: Hyperbaric Levobupivacaine 0.75%
Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
Other Names:
  • Bupinest 0.75% Pesado
Experimental: Levo-9.37
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Drug: Hyperbaric Levobupivacaine 0.75%
Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
Other Names:
  • Bupinest 0.75% Pesado
Active Comparator: Levo-11.25
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Drug: Hyperbaric Levobupivacaine 0.75%
Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
Other Names:
  • Bupinest 0.75% Pesado

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failed Spinal Block Rate
Time Frame: 15 minutes after dose
Failed Spinal Block Rate for each treatment group
15 minutes after dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Investigators

  • Principal Investigator: Fredy J Ariza, MD., MSc., Fundacion Clinica Valle del Lili
  • Study Chair: Marisol Badiel, MD., MSc., Unidad de Investigaciones Clínicas, Fundación Valle del Lili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 16, 2013

First Submitted That Met QC Criteria

June 16, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LevoBupi-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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