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