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

F

Fundacion Clinica Valle del Lili

Status and phase

Completed
Phase 4

Conditions

Disorder of Knee
Anesthesia

Treatments

Drug: Hyperbaric Levobupivacaine 0.75%

Study type

Interventional

Funder types

Other

Identifiers

NCT01881087
LevoBupi-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

180 participants in 3 patient groups

Levo-7.5 mg
Experimental group
Description:
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose.
Treatment:
Drug: Hyperbaric Levobupivacaine 0.75%
Levo-9.37
Experimental group
Description:
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose.
Treatment:
Drug: Hyperbaric Levobupivacaine 0.75%
Levo-11.25
Active Comparator group
Description:
Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Treatment:
Drug: Hyperbaric Levobupivacaine 0.75%

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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