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

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ClinicalTrials.gov Identifier: NCT02291094
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Fabricio Tavares Mendonca, Hospital de Base

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Lidocaine Drug: Remifentanil Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Infusion of Lidocaine and Remifentanil Perioperatively in Patients Undergoing Mastectomy: a Prospective, Randomized, Double-blind Study
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Active Comparator: Lidocaine group
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
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.

Active Comparator: Remifentanil group
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
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 Measures :
  1. Evaluation of post-operative pain [ Time Frame: Within the first 24 hours after surgery ]
    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 :
  1. Evaluation of perioperative side effects [ Time Frame: Within the first 24 hours after surgery ]
    Blood pressure, heart rate intraoperative, perioperative side effects



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291094


Sponsors and Collaborators
Hospital de Base
Investigators
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Principal Investigator: Fabricio T Mendonca, MD Hospital de Base do Distrito Federal, Brazil

Publications:
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Responsible Party: Fabricio Tavares Mendonca, MD, Hospital de Base
ClinicalTrials.gov Identifier: NCT02291094     History of Changes
Other Study ID Numbers: Lido01
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Fabricio Tavares Mendonca, Hospital de Base:
Intravenous lidocaine
Mastectomy
Pain

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Remifentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics