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:
Participant gender:
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.