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

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.

Conditions

• Anesthesia
• Cancer

Interventions

DRUG

Lidocaine IV

Will be sent to Group L a 10 ml syringe of 2% lidocaine and 200 ml of lidocaine solution at 8mg.ml-1 (80ml of 2% lidocaine associated with 120ml 0.9% sodium chloride) A syringe with 10 ml of solution and a bag with 200 ml of solution indistinguishable between the groups, with the identification of the patient by label prepared specifically for the study will be prepared by the Pharmacy personal. The bag and the solution will be sealed in a waterproof and opaque envelope and sent to the Operating Theatre (OT). The envelope will be stored in the refrigerator of the sector between 3º C and 8º C until the patient is sent to the operating room, when the drugs will be sent to the operating room. At the time designated for the start of the intervention, a bolus of 0.075 ml.kg-1 of the syringe solution, followed by 0.25 ml.kg-1.h-1 in the infusion pump of the solution in the bag will be administered.

DRUG

Saline

Group S will be sent a 10 ml syringe of 1% lidocaine and 200 ml of saline solution (0.9% sodium chloride) A syringe with 10 ml of solution and a bag with 200 ml of solution indistinguishable between the groups, with the identification of the patient by label prepared specifically for the study will be prepared by the Pharmacy personal. The bag and the solution will be sealed in a waterproof and opaque envelope and sent to the Operating Theatre (OT). The envelope will be stored in the refrigerator of the sector between 3º C and 8º C until the patient is sent to the operating room, when the drugs will be sent to the operating room. At the time designated for the start of the intervention, a bolus of 0.075 ml.kg-1 of the syringe solution, followed by 0.25 ml.kg-1.h-1 in the infusion pump of the solution in the bag will be administered.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil

  lead OTHER_GOV

Principal Investigators

• Bruno LC Araujo, MSc, EDAIC · Department of Anesthesiology, Hospital do Câncer II, Instituto Nacional do Câncer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-17

Primary Completion

2022-12-31

Completion

2023-12-31

Countries

• Brazil

Study Locations