We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoperative Intravenous Lidocaine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965796
First Posted: August 26, 2009
Last Update Posted: August 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.

Condition Intervention
Pain Intensity Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intraoperative Intravenous Lidocaine on Pain After Hysterectomy

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 24hours ]

Enrollment: 40
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Lidocaine
Lidocaine 2 mg/kg/h- during surgical procedure Saline
Other Name: Intravenous lidocaine

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT00965796


Locations
Brazil
Rioko K Sakata- Universidade Federal de São Paulo
São Paulo, Rua Botucatu-593, Brazil, 04023-062
Universidade Federal de São Paulo
São Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Rioko K Sakata, PhD Universidade Federal de São Paulo
  More Information

Responsible Party: Rioko K Sakata, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT00965796     History of Changes
Other Study ID Numbers: IO-Lido
First Submitted: August 24, 2009
First Posted: August 26, 2009
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Federal University of São Paulo:
Intravenous lidocaine
postoperative analgesia

Additional relevant MeSH terms:
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
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