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Intraoperative Intravenous Lidocaine

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00965796
First received: August 24, 2009
Last updated: August 25, 2009
Last verified: August 2009

August 24, 2009
August 25, 2009
May 2008
October 2008   (final data collection date for primary outcome measure)
Pain [ Time Frame: 24hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00965796 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Intraoperative Intravenous Lidocaine
Effect of Intraoperative Intravenous Lidocaine on Pain After Hysterectomy

The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain Intensity
Drug: Lidocaine
Lidocaine 2 mg/kg/h- during surgical procedure Saline
Other Name: Intravenous lidocaine
Experimental: Lidocaine, pain intensity and Saline
(2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure
Intervention: Drug: Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2008
October 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00965796
IO-Lido
No
Rioko K Sakata, Universidade Federal de São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Rioko K Sakata, PhD Universidade Federal de São Paulo
Federal University of São Paulo
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP