NCT02006966

Brief Summary

Systemic lidocaine infusion may improve the patients' chronic post surgical pain after video-assisted thoracic surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2016

Completed
Last Updated

April 1, 2019

Status Verified

December 1, 2016

Enrollment Period

2.6 years

First QC Date

December 4, 2013

Last Update Submit

March 28, 2019

Conditions

Lung Cancer(Primary, Metastatic)Benign Lung Mass Requiring Operation

Keywords

Systemic lidocainepostoperative painVideo-assisted thoracic surgeryVATS

Outcome Measures

Primary Outcomes (1)

  • Assessing pain score after operation

    Assessing pain score by Short-form McGill pain questionnaire at 2 months after operation

    2 months after operation

Study Arms (2)

Group L

EXPERIMENTAL

Intravenous lidocaine infusion group

Drug: Systemic intravenous lidocaine infusion

Group C

ACTIVE COMPARATOR

Intravenous normal saline infusion - control group

Drug: Normal saline infusion

Interventions

Systemic intravenous lidocaine infusionDRUG

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.

Group L
Normal saline infusionDRUG

In group C, the patients receive same volume of normal saline

Group C

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20 and 65 years
  • ASA class 1 and 2
  • Patients who are scheduled for video-assisted thoracic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Neoplasm MetastasisPain, Postoperative

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 10, 2013

Study Start

January 1, 2014

Primary Completion

August 22, 2016

Study Completion

August 22, 2016

Last Updated

April 1, 2019

Record last verified: 2016-12

Locations

KR(1)