Intraoperative Intravenous Lidocaine
Primary Purpose
Pain Intensity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Pain Intensity focused on measuring Intravenous lidocaine, postoperative analgesia
Eligibility Criteria
Inclusion Criteria:
- ASA 1 or 2, aged 18 to 60 years undergoing hysterectomy
Exclusion Criteria:
- Cardiac arrhythmia; myocardiopathy
- Altered cardiac conduction
- Psychiatric, hepatic or respiratory disease
- Patients receiving any type of analgesic during the week before surgery
Sites / Locations
- Rioko K Sakata- Universidade Federal de São Paulo
- Universidade Federal de São Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lidocaine, pain intensity and Saline
Arm Description
(2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure
Outcomes
Primary Outcome Measures
Pain
Secondary Outcome Measures
Full Information
NCT ID
NCT00965796
First Posted
August 24, 2009
Last Updated
August 25, 2009
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00965796
Brief Title
Intraoperative Intravenous Lidocaine
Official Title
Effect of Intraoperative Intravenous Lidocaine on Pain After Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.
Detailed Description
Study design A prospective, randomized, double-blind study was conducted according to ethical guidelines for research involving humans. The study was approved by the Ethics Committee of the institution and all patients signed a free informed consent form. The patients were randomly allocated to two groups consisting of the same number of subjects by drawing lots.
One physician prepared the solutions and handed them over to the anesthetist who was unaware of the content of the solutions. The volume of the solutions was the same. The researcher was unaware to which group the patient belonged until the end of the study.
Exclusion criteria Excluded from the study were patients with cardiac arrhythmia; myocardiopathy; altered cardiac conduction; psychiatric, hepatic or respiratory disease; and patients receiving any type of analgesic during the week before surgery.
Patients Forty women (ASA 1 or 2) aged 18 to 60 years undergoing hysterectomy were studied.
Treatment Patients of group 1 (n = 20) received lidocaine (2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure.
Anesthesia Oral midazolam (15 mg) was administered one hour before anesthesia as pre-anesthetic medication. Anesthesia was induced with 5 µg/kg fentanyl and 2 mg/kg propofol. Neuromuscular block was maintained with atracurium. Anesthesia was maintained with O2/isoflurane.
Patient assessment The supplemental morphine doses necessary during the first 24 h and the time to first analgesic request were recorded. Pain intensity was evaluated at rest on a numerical scale ranging from 0 to 10 (0 = no pain and 10 = most intense pain possible) at the following times: T0 (immediately after arousal), and 6, 12, 18 and 24 h after arousal. Side effects were recorded.
Statistical analysis The results were analyzed statistically with the Instat Graph 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, body mass index, duration of anesthesia and surgery, time to first analgesic supplementation, total amount of morphine, pain intensity, and isoflurane consumed; Student t-test for weight and height; and Friedman test for pain intensity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Intensity
Keywords
Intravenous lidocaine, postoperative analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine, pain intensity and Saline
Arm Type
Experimental
Arm Description
(2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Intravenous lidocaine
Intervention Description
Lidocaine 2 mg/kg/h- during surgical procedure Saline
Primary Outcome Measure Information:
Title
Pain
Time Frame
24hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1 or 2, aged 18 to 60 years undergoing hysterectomy
Exclusion Criteria:
Cardiac arrhythmia; myocardiopathy
Altered cardiac conduction
Psychiatric, hepatic or respiratory disease
Patients receiving any type of analgesic during the week before surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rioko K Sakata- Universidade Federal de São Paulo
City
São Paulo
State/Province
Rua Botucatu-593
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
12. IPD Sharing Statement
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Intraoperative Intravenous Lidocaine
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