Clinical Trials Logo
  1. Home
  2. Anesthesia
  3. NCT01881087
  4. Details
NCT01881087 Clinical Trial

Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy

Anesthesia Clinical Trial

— levobupi  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01881087
Other study ID # LevoBupi-003
Secondary ID
Status Completed
Phase Phase 4
First received June 16, 2013
Last updated June 19, 2013
Start date June 2006
Est. completion date July 2010

Study information
Verified date June 2013
Source Fundacion Clinica Valle del Lili
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date July 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Colombia Fundación Valle del Lili Cali Valle del Cauca

Sponsors (1)
Lead Sponsor Collaborator
Fundacion Clinica Valle del Lili

Country where clinical trial is conducted

Colombia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Probability of motor block Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75% 200 minutes No
Secondary Failed Spinal Block Rate Failed Spinal Block Rate for each treatment group 15 minutes after dose Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas

External Links