Clinical trial NCT01608360: The Effect of Intravenous Lidocaine on Pain After Thyroidectomy
Official title: Intravenous Lidocaine for Effective Pain Relief After Thyroidectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Pain
Lidocaine
Intravenous
Thyroidectomy
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Total thyroidectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics

Primary outcomes:
measure: Postoperative pain measured using Visual analogue scale at postoperative 2hour
timeFrame: post op 2hour
Secondary outcomes:
measure: visual analogue scale 4hour
timeFrame: post op 4 hour
measure: visual analogue scale 8 hour
timeFrame: Post op 8 hour
measure: Visual analogue scale 12hour
timeFrame: Post op 12 hour
measure: visual analogue scale 24hour
timeFrame: Post op 24 hour
measure: visual analogue scale 48 hour
timeFrame: Post op 48hour
measure: Opioid consumption 2hour
timeFrame: post op 2hour
measure: Opioid consumption 4 hour
timeFrame: Post op 4 hour
measure: Opioid consumption 8hour
timeFrame: Post op 8 hour
measure: Opioid consumption 12 hour
timeFrame: Post op 12 hour
measure: Opioid consumption 24 hour
timeFrame: Post op 24 hour
measure: Opioid consumption 48 hour
timeFrame: Post op 48 hour
measure: FPB 2hour
timeFrame: Post op 2 hour
measure: FPB 4hour
timeFrame: Post op 4 hour
measure: FPB 8 hour
timeFrame: Post op 8 hour
measure: FPB 12 hour
timeFrame: Post op 12 hour
measure: FPB 24hour
timeFrame: Post op 24hour
measure: FPB 48 hour
timeFrame: Post op 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChungAng University
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyun Kang, Ph.D
role: STUDY_CHAIR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Eun Jin Ahn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.