Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy

Thyroid Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907997
• Other study ID #: 4-2013-0342
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: June 5, 2015
• Start date: July 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 20-65

• ASA class I and II

• Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Drug:
• Systemic intravenous lidocaine infusion
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.
• normal saline infusion
In group C, the patients receive same volume of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery 40(QoR-40) score	Assessing change of the Quality of recovery 40(QoR-40) score between 24hours before and after operation	24hours after operation day	No
Secondary	Assessing the presence of chronic postsurgical pain(CPSP)		24hours after operation day	No
Secondary	aspect and site of CPSP		24hours after operation day	No