Effect of Intravenous Infusion of Lidocaine and Remifentanil Perioperatively in Patients Undergoing Mastectomy

NCT02291094 | Completed Phase 4

• 1 other identifier: Lido01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare quality of perioperative analgesia of lidocaine and remifentanil intravenously in surgical interventions for the treatment of breast cancer.

Conditions

Postoperative Pain

Keywords

Intravenous lidocaine; Mastectomy; Pain

Outcome Measures

Primary Outcomes (1)

• Evaluation of post-operative pain

  Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or unbearable pain), Verbal Rating Scale (VRS), consisting of a list of phrases (no pain, mild pain, moderate pain, intense pain, maximum pain) and qualification of pain assessed by the amount of analgesics required postoperatively and the time to request them.

  Within the first 24 hours after surgery

Secondary Outcomes (1)

• Evaluation of perioperative side effects

  Within the first 24 hours after surgery

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

Patients in lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.

Drug: Lidocaine

Remifentanil group

ACTIVE COMPARATOR

Patients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.

Drug: Remifentanil

Interventions

Lidocaine DRUG

Patients in intravenous lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.

Lidocaine group

Remifentanil DRUG

Patients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.

Remifentanil group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients scheduled for elective surgery performed mastectomy;
• Physical Status P1 and P2 of the American Society of Anesthesiology (ASA);

You may not qualify if:

• Patients with less than 18 years and above 75 years of age;
• Patients who are allergic to morphine and / or lidocaine;
• Patients with chronic pain;
• Patients with severe hepatic disease;
• Patients with severe renal disease;
• Patients with neurological disorders;
• Patients included in other clinical currently or within the past three months under general anesthesia studies;
• Patients who refuse to participate in the study;
• Any other condition that in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;

Sponsors & Collaborators

• Hospital de Base: lead

Related Publications (1)

• Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

  PMID: 21061107 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Lidocaine; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fabricio T Mendonca, MD

  Hospital de Base do Distrito Federal, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 14, 2014
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2014-11