- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006966
The Impact of Intraoperative Systemic Lidocaine Infusion on Chronic Postoperative Pain After Video-assisted Thoracic Surgery (VATS)
March 28, 2019 updated by: Yonsei University
Systemic lidocaine infusion may improve the patients' chronic post surgical pain after video-assisted thoracic surgery
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 20 and 65 years
- ASA class 1 and 2
- Patients who are scheduled for video-assisted thoracic surgery
Exclusion Criteria:
- Allergy to local anesthetics or contraindication to use of lidocaine
- Pregnancy
- Severe cardiovascular disease
- Renal failure
- Liver failure
- Neurologic and psychologic disease
- Chronic treatment with analgesics or chronic pain patients
- Previous history of thoracic surgery (open or video-assisted)
- Patients' refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group L
Intravenous lidocaine infusion group
|
In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia.
After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.
|
ACTIVE_COMPARATOR: Group C
Intravenous normal saline infusion - control group
|
In group C, the patients receive same volume of normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing pain score after operation
Time Frame: 2 months after operation
|
Assessing pain score by Short-form McGill pain questionnaire at 2 months after operation
|
2 months after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ACTUAL)
August 22, 2016
Study Completion (ACTUAL)
August 22, 2016
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (ESTIMATE)
December 10, 2013
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 4-2013-0693
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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