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

NCT04741880 | Unknown Phase 2 DMC

• 1 other identifier: 40904720.3.0000.5274
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 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

Keywords

Spinal Anesthesia; Bupivacaine; Lidocaine; Regression of the sensory block

Outcome Measures

Primary Outcomes (1)

• Time to T12 regression of the sensory block

  Time between the injection of bupivacaine into the subarachnoid space and the regression of sensory block to T12 dermatome (in minutes)

  Period: Day 0 postoperative

Secondary Outcomes (17)

• Time to motor block regression

  Day 0 postoperative

• Most rostral dermatome achieved by the sensory block

  Day 0 postoperative

• Time to two-segment regression of the sensory block

  Day 0 postoperative

• Propofol dose at the operating room

  Intraoperative

• Time to the first opioid rescue

  Intraoperative

Study Arms (2)

Group L (Lidocaine)

EXPERIMENTAL

Lidocaine bolus 1.5 mg.kg-1 intravenous before the onset of lidocaine infusion Lidocaine 2mg.kg-1.h-1

Drug: Lidocaine IV

Group S (saline solution)

PLACEBO COMPARATOR

Lidocaine bolus 0.75 mg.kg-1 intravenous before the onset of saline infusion Saline solution infusion

Drug: Saline

Interventions

Lidocaine IV DRUG

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.

Also known as: Lidocaine

Group L (Lidocaine)

Saline DRUG

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.

Also known as: 0.9% sodium chloride

Group S (saline solution)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Hospital de Câncer II, INCA

Rio de Janeiro, 20270212, Brazil

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Neoplasms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bruno LC Araujo, MSc, EDAIC

  Department of Anesthesiology, Hospital do Câncer II, Instituto Nacional do Câncer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno LC Araujo, MSc, EDAIC

CONTACT

+5521988400944; brunoaraujomed@yahoo.com.br

Andreia C de Melo, PhD

CONTACT

andreia.melo@inca.gov.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators appointed for executing the protocol will not have access to the group in which the patient will be allocated. Randomization will be performed by automated system (RedCap) and at the time the investigator assigned for preparing the medication in the central pharmacy of the unit is requested to send the infusion. Only staff in the pharmacy sector will have access to the allocation group. The groups will remain masked even after closing the database and sending the data sheet for statistical analysis by the principal investigator, there will be no identification of the intervention performed in each group (lidocaine versus saline solution). After the end of the analysis, the result will be opened to finish the description of the results and develop the discussion of the findings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 5, 2021
• Study Start: June 17, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)