Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy

NCT01881087 | Completed Phase 4 Results DMC

• 1 other identifier: LevoBupi-003
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Knee; Anesthesia

Keywords

Knee Arthroscopy; Levobupivacaine; Spinal Anesthesia; Motor Block

Outcome Measures

Primary Outcomes (1)

• Probability of Motor Block

  Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%

  200 minutes

Secondary Outcomes (1)

• Failed Spinal Block Rate

  15 minutes after dose

Study Arms (3)

Levo-7.5 mg

EXPERIMENTAL

Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.

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.

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.

Drug: Hyperbaric Levobupivacaine 0.75%

Interventions

Hyperbaric Levobupivacaine 0.75% DRUG

Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.

Also known as: Bupinest 0.75% Pesado

Levo-11.25; Levo-7.5 mg; Levo-9.37

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundación Valle del Lili

Cali, Valle del Cauca Department, 76001000, Colombia

Location

Related Links

• 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.pdf

Results Point of Contact

• Title: Dr. Fredy Ariza, MD., MSc., PhD(a).
• Organization: Fundación Valle del Lili

fredyariza@hotmail.com

+57 3319090

Study Officials

• Fredy J Ariza, MD., MSc.

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

• Marisol Badiel, MD., MSc.

  Unidad de Investigaciones Clínicas, Fundación Valle del Lili

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Epidemiologist

Study Record Dates

• First Submitted: June 16, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)