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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levo-7.5 mg | Experimental | Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. |
|
| Levo-9.37 | Experimental | Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. |
|
| Levo-11.25 | Active Comparator | Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Motor Block | Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75% | 200 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Failed Spinal Block Rate | Failed Spinal Block Rate for each treatment group | 15 minutes after dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Valle del Lili | Cali | Valle del Cauca Department | 76001000 | Colombia |
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| Label | URL |
|---|---|
| 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 | View source |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Levo-7.5 mg | 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. |
| FG001 | Levo-9.37 | 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. |
| FG002 | Levo-11.25 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levo-7.5 mg | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Probability of Motor Block | Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75% | Posted | Number | percentage of motor block | 200 minutes |
|
24 hours
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levo-7.5 mg | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fredy Ariza, MD., MSc., PhD(a). | Fundación Valle del Lili | +57 3319090 | 4122 | fredyariza@hotmail.com |
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|
| Levo-9.37 |
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. |
| BG002 | Levo-11.25 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| OG002 | Levo-11.25 | 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. |
|
|
| Secondary | Failed Spinal Block Rate | Failed Spinal Block Rate for each treatment group | Posted | Count of Participants | Participants | 15 minutes after dose |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Levo-9.37 | 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. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG002 | Levo-11.25 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
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