The Effect of Intravenous Lidocaine on Pain After Thyroidectomy

NCT01608360 | Unknown Phase 4

• 1 other identifier: ChungAngUH3
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Pain; Lidocaine; Intravenous; Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain measured using Visual analogue scale at postoperative 2hour

  Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks ont the line the that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 2hour.

  post op 2hour

Secondary Outcomes (17)

• visual analogue scale 4hour

  post op 4 hour

• visual analogue scale 8 hour

  Post op 8 hour

• Visual analogue scale 12hour

  Post op 12 hour

• visual analogue scale 24hour

  Post op 24 hour

• visual analogue scale 48 hour

  Post op 48hour

Study Arms (2)

Intravenous lidocaine injection group

ACTIVE COMPARATOR

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.

Drug: Intravenous lidocaine injection

Placebo control group

PLACEBO COMPARATOR

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

Drug: Intravenous normal saline injection

Interventions

Intravenous lidocaine injection 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.

Also known as: IV lidocaine

Intravenous lidocaine injection group

Intravenous normal saline injection DRUG

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

Also known as: IV saline

Placebo control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total thyroidectomy

You may not qualify if:

• mental change
• allergy to local anesthetics

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

ChungAng University

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 27379388 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hyun Kang, Ph.D

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

  STUDY CHAIR

• Eun Jin Ahn

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Kang, Ph.D

CONTACT

82-2-6299-2571; roman00@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 26, 2012
• First Posted: May 31, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

KR (1)