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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lidocaine
Remifentanil
Sponsored by
Hospital de Base
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Intravenous lidocaine, Mastectomy, Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Lidocaine group

    Remifentanil group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Evaluation of perioperative side effects
    Blood pressure, heart rate intraoperative, perioperative side effects

    Full Information

    First Posted
    November 11, 2014
    Last Updated
    November 23, 2014
    Sponsor
    Hospital de Base
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02291094
    Brief Title
    Effect of Intravenous Infusion of Lidocaine and Remifentanil Perioperatively in Patients Undergoing Mastectomy
    Official Title
    Effect of Intravenous Infusion of Lidocaine and Remifentanil Perioperatively in Patients Undergoing Mastectomy: a Prospective, Randomized, Double-blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital de Base

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The opioid analgesics are commonly used in clinical practice for pain management in the perioperative period. However, many side effects are associated with its use, such as respiratory depression, nausea, vomiting, drowsiness, itching, urinary retention, constipation, hyperalgesia and impaired immune function. Therefore, alternative techniques and drugs have been used to replace their use. One is the intravenous infusion of lidocaine, a local anesthetic widely used in anesthetic practice. Studies show that the use of lidocaine during surgery significantly decreased postoperative pain. The mechanisms of analgesia this local anesthetic in surgical trauma may be blocking neuronal transmission in the lesion site alleviating neurogenic response, and anti-inflammatory systemic intrinsic activity. Intraoperative lidocaine promotes, besides analgesia, decreased consumption of both inhalational anesthetic and opioids; faster return of bowel movements; decreasing the production of interleukins and reduction of airway reactivity. This anesthetic also has significant anti-inflammatory properties, reduces cytokine release both in vitro and in vivo by inhibiting neutrophil activation. Besides there are few studies with use of intravenous lidocaine during the perioperative period, the intravenous injection of local anesthetic still arouses oddity among professionals; therefore, the investigators interest in the subject. The patients underwent a prospective, randomized, double blind, in which the examiners responsible for intra and post operative will not know which group they were randomly allocated: Lidocaine group (n = 30) 3 mg / kg / h or Remifentanil group (n = 30) 0.1 mcg / kg / min. In the clinical record, the following information will be emphasized: Blood pressure and heart rate intraoperative, perioperative side effects, 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. The results were analyzed statistically with the XLSTAT for Excel program using parametric and nonparametric tests, depending on the nature of the variables studied. Measures of central tendency (means) and dispersion (standard deviation) were used. The level of significance was set at < 0.05. The following tests were used: Mann-Whitney test for age, duration of anesthesia and surgery, time to first analgesic supplementation, total amount of analgesics, pain intensity; Student t-test for weight and height.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Intravenous lidocaine, Mastectomy, Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Remifentanil group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evaluation of post-operative pain
    Description
    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.
    Time Frame
    Within the first 24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Evaluation of perioperative side effects
    Description
    Blood pressure, heart rate intraoperative, perioperative side effects
    Time Frame
    Within the first 24 hours after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients scheduled for elective surgery performed mastectomy; Physical Status P1 and P2 of the American Society of Anesthesiology (ASA); Exclusion Criteria: 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;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabricio T Mendonca, MD
    Organizational Affiliation
    Hospital de Base do Distrito Federal, Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21061107
    Citation
    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.
    Results Reference
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    Effect of Intravenous Infusion of Lidocaine and Remifentanil Perioperatively in Patients Undergoing Mastectomy

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