Evaluation of Intravenous Lidocaine and Time to Regression of the Sensory Block After Spinal Anesthesia (ELSA Trial)

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 other favorable outcomes. However, this therapeutic intervention has not yet been adequately evaluated by clinical trials when associated with regional anesthesia. The aim of this study is to evaluate whether the use of intravenous lidocaine in continuous infusion during spinal anesthesia with isobaric bupivacaine alters the time to regression of sensory block in patients undergoing surgical procedures for the treatment of bone and connective tissue tumor surgeries. This will be a triple-blind randomized trial. The sample size estimated was 66 patients. The study will include all patients who meet the pre-established inclusion and exclusion criteria, choose to participate, and agree with the Informed Consent Form. The main anesthetic technique will be spinal anesthesia with 13 mg of isobaric bupivacaine. Patients will be allocated in two groups in a blindly after randomization: Group S (lidocaine 0.75mg.kg-1 in bolus followed by infusion of saline solution) and Group L (lidocaine 1.5 mg.kg-1 followed by continuous infusion of lidocaine solution at 2 mg.kg-1.h-1). The primary outcome will be the time to T12 regression of the sensory block. Will also be evaluated: time to regression of the motor block, most rostral dermatome achieved by the sensory block, time to two-segment regression oh the sensory block, propofol dose in the operating room, postoperative pain score at rest, pain at movement score, quality of recovery, use of opioids in the postoperative period, nausea or vomiting, dizziness, shivering, arrhythmias, hypotension, urinary retention, and length of stay. The records will be assigned to the RedCap database. The data will be extracted without identification of the allocation groups for the R software and the groups will be revealed to the researcher after the end of the statistical analysis to write the summary of the results. The results will be submitted to scientific journals afterward.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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