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

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Systemic intravenous lidocaine infusion
normal saline infusion
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group L

Group C

Arm Description

Intravenous lidocaine infusion group

Intravenous normal saline infusion - control group

Outcomes

Primary Outcome Measures

Quality of recovery 40(QoR-40) score
Assessing change of the Quality of recovery 40(QoR-40) score between 24hours before and after operation

Secondary Outcome Measures

Assessing the presence of chronic postsurgical pain(CPSP)
aspect and site of CPSP

Full Information

First Posted
July 17, 2013
Last Updated
June 5, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01907997
Brief Title
Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Experimental
Arm Description
Intravenous lidocaine infusion group
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Intravenous normal saline infusion - control group
Intervention Type
Drug
Intervention Name(s)
Systemic intravenous lidocaine infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline infusion
Intervention Description
In group C, the patients receive same volume of normal saline
Primary Outcome Measure Information:
Title
Quality of recovery 40(QoR-40) score
Description
Assessing change of the Quality of recovery 40(QoR-40) score between 24hours before and after operation
Time Frame
24hours after operation day
Secondary Outcome Measure Information:
Title
Assessing the presence of chronic postsurgical pain(CPSP)
Time Frame
24hours after operation day
Title
aspect and site of CPSP
Time Frame
24hours after operation day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27896411
Citation
Choi KW, Nam KH, Lee JR, Chung WY, Kang SW, Joe YE, Lee JH. The Effects of Intravenous Lidocaine Infusions on the Quality of Recovery and Chronic Pain After Robotic Thyroidectomy: A Randomized, Double-Blinded, Controlled Study. World J Surg. 2017 May;41(5):1305-1312. doi: 10.1007/s00268-016-3842-1.
Results Reference
derived

Learn more about this trial

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

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