Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy

Phase 4

Completed

• Conditions: Disorder of Knee; Anesthesia
• Interventions: Drug: Hyperbaric Levobupivacaine 0.75%

• Registration Number: NCT01881087
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-06
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Study First Submitted: 2013-06-16
• Study First Submitted QC: 2013-06-16
• Study First Posted: 2013-06-19
• Status Verified: 2017-04
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levo-11.25	Hyperbaric Levobupivacaine 0.75%	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Levo-9.37	Hyperbaric Levobupivacaine 0.75%	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Levo-7.5 mg	Hyperbaric Levobupivacaine 0.75%	Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.

Primary Outcome Measures

Name	Time	Method
Probability of Motor Block	200 minutes	Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%

Secondary Outcome Measures

Name	Time	Method
Failed Spinal Block Rate	15 minutes after dose	Failed Spinal Block Rate for each treatment group

Trial Locations

Locations (1)

Fundación Valle del Lili; 🇨🇴 Cali, Valle del Cauca, Colombia