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

• Sponsor: Fundacion Clinica Valle del Lili (Other)
• Overall Status: Completed
• CT.gov ID: NCT01881087
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Duration (Months): 49
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jun 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Probability of Motor Block [200 minutes]

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

Secondary Outcome Measures

1. Failed Spinal Block Rate [15 minutes after dose]

   Failed Spinal Block Rate for each treatment group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundación Valle del Lili	Cali	Valle del Cauca	Colombia	76001000

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Fredy Ariza, Anesthesiologist, Epidemiologist, Fundacion Clinica Valle del Lili
• ClinicalTrials.gov Identifier: NCT01881087
• Other Study ID Numbers: LevoBupi-003
• First Posted: Jun 19, 2013
• Last Update Posted: Jul 12, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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, Anesthesiologist, Epidemiologist, Fundacion Clinica Valle del Lili: Knee Arthroscopy; Levobupivacaine; Spinal Anesthesia; Motor Block
• Additional relevant MeSH terms: Levobupivacaine

Study Results

Participant Flow

Arm/Group Title	Levo-7.5 mg	Levo-9.37	Levo-11.25
Arm/Group Description	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. 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.
Period Title: Overall Study
STARTED	60	61	62
COMPLETED	59	61	60
NOT COMPLETED	1	0	2

Baseline Characteristics

Arm/Group Title	Levo-7.5 mg	Levo-9.37	Levo-11.25	Total
Arm/Group Description	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. 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.	Total of all reporting groups
Overall Participants	59	61	60	180
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42 (13)	47 (13)	44 (12)	44.3 (12)
Sex: Female, Male (Count of Participants)
Female	32 54.2%	28 45.9%	32 53.3%	92 51.1%
Male	27 45.8%	33 54.1%	28 46.7%	88 48.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	59 100%	61 100%	60 100%	180 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Colombia	59 100%	61 100%	60 100%	180 100%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	74.7 (12.3)	73.3 (11.4)	75.7 (13.9)	74.5 (12.5)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	168 (9)	167 (6)	168 (9)	168 (8)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levo-7.5 mg	Levo-9.37	Levo-11.25
Arm/Group Description	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. 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.
Measure Participants	59	61	60
Number [percentage of motor block]	5	20	27

2. Secondary Outcome

Title	Failed Spinal Block Rate
Description	Failed Spinal Block Rate for each treatment group
Time Frame	15 minutes after dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levo-7.5 mg	Levo-9.37	Levo-11.25
Arm/Group Description	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. 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.	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. 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.
Measure Participants	59	61	60
Count of Participants [Participants]	2 3.4%	3 4.9%	1 1.7%

Adverse Events

Time Frame	24 hours
Adverse Event Reporting Description	Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
Arm/Group Title	Levo-7.5 mg		Levo-9.37		Levo-11.25
Arm/Group Description	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. 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.		Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. 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.		Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. 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.
All Cause Mortality
	Levo-7.5 mg		Levo-9.37		Levo-11.25
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/61 (0%)		0/60 (0%)
Serious Adverse Events
	Levo-7.5 mg		Levo-9.37		Levo-11.25
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/61 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Levo-7.5 mg		Levo-9.37		Levo-11.25
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/61 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.