Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Disorder of Knee, Anesthesia

Intervention / Treatment
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* Drug: Hyperbaric Levobupivacaine 0.75%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of Motor Block | 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 | Failed Spinal Block Rate for each treatment group | 15 minutes after dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroscopy, Levobupivacaine, Spinal Anesthesia, Motor Block