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

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ClinicalTrials.gov Identifier: NCT01881087
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Fredy Ariza, Fundacion Clinica Valle del Lili

Brief 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.

Condition or disease Intervention/treatment Phase
Disorder of Knee Anesthesia Drug: Hyperbaric Levobupivacaine 0.75% Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy: A Double Blind, Randomized Clinical Trial Comparing Three Low Doses
Study Start Date : June 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2010

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 Name: 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 Name: 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 Name: Bupinest 0.75% Pesado




Primary Outcome Measures :
  1. Probability of Motor Block [ Time Frame: 200 minutes ]
    Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%


Secondary Outcome Measures :
  1. Failed Spinal Block Rate [ Time Frame: 15 minutes after dose ]
    Failed Spinal Block Rate for each treatment group



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881087


Locations
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Colombia
Fundación Valle del Lili
Cali, Valle del Cauca, Colombia, 76001000
Sponsors and Collaborators
Fundacion Clinica Valle del Lili
Investigators
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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

Additional Information:
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Responsible Party: Fredy Ariza, Anesthesiologist, Epidemiologist, Fundacion Clinica Valle del Lili
ClinicalTrials.gov Identifier: NCT01881087     History of Changes
Other Study ID Numbers: LevoBupi-003
First Posted: June 19, 2013    Key Record Dates
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/)

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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
Keywords provided by Fredy Ariza, Fundacion Clinica Valle del Lili:
Knee Arthroscopy
Levobupivacaine
Spinal Anesthesia
Motor Block
Additional relevant MeSH terms:
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Anesthetics
Levobupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents