Status:
UNKNOWN
Evaluation of Intravenous Lidocaine and Time to Regression of the Sensory Block After Spinal Anesthesia (ELSA Trial)
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Anesthesia
Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The use of intravenous lidocaine in continuous infusion in the perioperative period is associated with a reduction in postoperative pain scores, opioid use, incidence of nausea and vomiting, among oth...
Detailed Description
Hypotheses: Null hypothesis H0: The time to T12 regression of the sensory block after administration of isobaric bupivacaine is EQUAL with or without the use of intravenous lidocaine in continuous i...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years-old
- The American Society of Anesthesiologists (ASA) physical status classification from I to III
- To be submitted to:
- \- Spinal Anesthesia
- \- For surgeries performed by the Bone and Connective Tissue (TOC) service
- \- Involving lower limbs and inguinal region requiring sensory block level up to the T12 dermatome (except for larger amputations and bone resections)
- \- Expected duration of less than 120 minutes
- \- In supine position
- That they voluntarily decide to participate in the study
Exclusion
- Coagulation disorder that prevents the execution of the blockade:
- \- International normalized ratio for prothrombin (INR) time and activity \> 1.5
- \- Activated partial thromboplastin time ratio (PTTa) \>1.5
- \- Use of enoxaparin up to 40mg/day less than 12h before the procedure
- \- Use of enoxaparin above 40mg/day less than 24hours before the procedure
- \- Use of oral anticoagulant or platelet aggregation inhibitors in a lower interval than recommended for spinal block
- \- Other coagulation disorders that prevent spinal anesthesia
- Moderate or severe left ventricular systolic dysfunction (defined by the presence of left ventricle ejection fraction below 40%)
- Sinus bradycardia (FC \< 50 beats per minute)
- Relevant cardiac conduction system disorders (e.g. atrium ventricular block greater than first-degree, Wolf-Parkinson-White syndrome)
- Clinically significant arrhythmia (e.g. atrial fibrillation)
- Body mass index (BMI) than \> 35 mg.kg-1
- Previous diagnosis of liver cirrhosis
- Creatinine clearance \< 30 ml/min/1.73m2 estimated by the method of the Modification of Diet in Renal Disease (MDRD) study group
- Infection at the site of lumbar puncture
- Previous spinal surgery
- Allergy to local anesthetics amino-amides
- Difficulty in communication, understanding or cognitive deficit that prevents adequate oral response to study the study forms
- Pre-existing neurological lesion in topography to be evaluated motor block
- Documented or suspected spinal or central nervous system metastasis
- Regular use of strong opioids at a dose equal or greater than 60 mg of oral morphine equivalents per day
- Desire to withdraw from the study at any time of its execution
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04741880
Start Date
June 17 2021
End Date
December 1 2023
Last Update
July 30 2021
Active Locations (1)
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1
Hospital de Câncer II, INCA
Rio de Janeiro, Brazil, 20270212