The Effect of Intravenous Lidocaine on Pain After Thyroidectomy

NCT ID: NCT01608360

Last Updated: 2014-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.

A total 56 patients will be randomized into one of two groups(group C or group I) based on Excel number generation.

Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous lidocaine injection group

Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Group Type ACTIVE_COMPARATOR

Intravenous lidocaine injection

Intervention Type DRUG

Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Placebo control group

Patients in Group C (placebo control group) received normal saline intravenous injection

Group Type PLACEBO_COMPARATOR

Intravenous normal saline injection

Intervention Type DRUG

The patients in Group C (placebo control group) received normal saline intravenous injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous lidocaine injection

Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Intervention Type DRUG

Intravenous normal saline injection

The patients in Group C (placebo control group) received normal saline intravenous injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IV lidocaine IV saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Total thyroidectomy

Exclusion Criteria

* mental change
* allergy to local anesthetics
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hyun Kang

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyun Kang, Ph.D

Role: STUDY_CHAIR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Eun Jin Ahn

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ChungAng University

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hyun Kang, Ph.D

Role: CONTACT

82-2-6299-2571

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

SeongDeok Kim, M.D. & Ph.D.

Role: primary

82-2-6299-2571

References

Explore related publications, articles, or registry entries linked to this study.

Choi GJ, Kang H, Ahn EJ, Oh JI, Baek CW, Jung YH, Kim JY. Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. World J Surg. 2016 Dec;40(12):2941-2947. doi: 10.1007/s00268-016-3619-6.

Reference Type DERIVED
PMID: 27379388 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ChungAngUH3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.