NCT01907997

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

July 17, 2013

Last Update Submit

June 5, 2015

Conditions

Keywords

Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Assessing the presence of chronic postsurgical pain(CPSP)

    24hours after operation day

  • aspect and site of CPSP

    24hours after operation day

Study Arms (2)

Group L

EXPERIMENTAL

Intravenous lidocaine infusion group

Drug: Systemic intravenous lidocaine infusion

Group C

PLACEBO COMPARATOR

Intravenous normal saline infusion - control group

Drug: normal saline infusion

Interventions

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

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 20-65
  • ASA class I and II
  • Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy

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

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

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Thyroid NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 25, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations