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  • Status : Approved
    • First Submitted Date : 2018/12/05
    • Registered Date : 2019/02/12
    • Last Updated Date : 2019/01/21
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1. Background

Background Information
CRIS
Registration Number
KCT0003493 
Unique Protocol ID CHAMC 2018-11-007 
Public/Brief Title A prospective study to determine whether intravenous infusion of lidocaine reduces pain after hysteroscopic surgery 
Scientific Title Effect of preoperative intravenous lidocaine on postoperative pain following hysteroscopic surgery  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol  
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number CHAMC 2018-11-007 
Approval Date 2018-11-27 
Institutional Review Board  
Name Institutional Review Board, CHA Bundang Medical Center, CHA University 
Address 59, Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 
Telephone 031-780-5314 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jiyoung Lee 
Title Assistant professor 
Telephone +82-31-780-1838 
Affiliation Bundang CHA General Hospital 
Address 59, Yatap-ro, Bundang-gu, Seongnam 
Contact Person for Public Queries
Name Jiyoung Lee 
Title Assistant professor 
Telephone +82-31-780-1838 
Affiliation Bundang CHA General Hospital 
Address 59, Yatap-ro, Bundang-gu, Seongnam 
Contact Person for Updating Information
Name Jiyoung Lee 
Title Assistant professor 
Telephone +82-31-780-1838 
Affiliation Bundang CHA General Hospital 
Address 59, Yatap-ro, Bundang-gu, Seongnam 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-12-11 , Actual
Target Number of Participant 138
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Bundang CHA General Hospital 
Recruitment Status Recruiting  
Date of First Enrollment 2018-12-11 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Bundang CHA General Hospital 
Organization Type Medical Institute  
Project ID CHAMC 2018-11-007 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Bundang CHA General Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Most of the patients who underwent hysteroscopic or polypectomy and myomectomy are common minimally invasive surgery in gynecology. Most of them are ambulatory surgery under general anesthesia. Postoperative pain is usually not severe, but since most patients are discharged from hospital on the day of surgery, it is needed hospitalization to control the pain. In addition, because they are ambulatory patients, the administration of narcotic analgesics, which may cause vomiting, sedation or respiratory depression after surgery, is limited, so they usually use non-narcotic analgesics.
Pain is caused by manipulation and expansion of the cervix, intrauterine manipulation, and hydrostatic pressure.
Lidocaine is an amide-based local anesthetic that has analgesic, anti-hyperalgesic and anti-inflammatory effects. Analgesic effects selectively inhibit pain transmission in the spinal cord and reduce tonic neural discharge in activated peripheral nerve fibers.
Intravenous lidocaine administration in a variety of general anesthesia operations including thyroidectomy, gynecologic laparoscopic surgery, cesarean section and laparoscopic cholecystectomy showed postoperative pain relief, reduction of administration of narcotic analgesics and rapid rehabilitation. Several meta-studies have shown that it is effective in abdominal surgery including laparoscopic surgery. However, no studies have reported the efficacy of intravenous lidocaine in hysteroscopic surgery.
Most of the papers that studied lidocaine were injected with 1.5-2 mg/kg/h after 1-2 mg/kg intravenous bolus injection, which was about 2-4 times higher than the 1.5 mg/kg intravenous bolus injection of our study. There was no serious adverse event with high doses. In rare cases, bradycardia, arrhythmia, lightheadedness, dizziness, and visual disturbances have occurred.
The recommended anesthesia method for patients with outpatient surgery is a propofol-based anesthesia to prevent vomiting after surgery and a narcotic analgesic for pain control. Currently, propofol-based anesthesia is performed in hysteroscopic surgery.
In this study, we investigated the effect of lidocaine 1.5 mg/kg bolus on postoperative acute pain before induction of propofol in the induction of anesthesia.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Prospective    
Target Number of Participant 138
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
control group 
Cohort/Group
Description
When ready for hysteroscopic surgery, the same volume of normal saline and propofol 2-2.5 mg/kg intravenous bolus are injected and propofol 6-10 mg/kg/ hr is continuously injected. After end of operation, patients would be sent to PACU (post anesthesia care unit). And then, we will record pain and PONV (postoperative nausea and vomiting) score, and administered analgesics and antiemetics. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
lidocaine group 
Cohort/Group
Description
When ready for hysteroscopic surgery, lidocaine 1.5 mg/kg and propofol 2-2.5 mg/kg intravenous bolus are injected and propofol 6-10 mg/kg/ hr is continuously injected. After end of operation, patients would be sent to PACU (post anesthesia care unit). And then, we will record pain and PONV (postoperative nausea and vomiting) score, and administered analgesics and antiemetics. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description 19–65 year old patients performing hysteroscopic surgery at in Bundang CHA hospital.  
Sampling Method computer generated random number table  
Condition(s)/Problem(s) * Not Applicable
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 19 Year ~ 65 Year
Description Korean, American Society of Anesthesiologists’ physical status 1 or 2 undergoing elective hysteroscopic
surgery, Age of 19-65  
Exclusion Criteria pregnancy
difficulty in the expression of pain
who had taken an analgesics 24 h before surgery
allergy to lidocaine
Body mass index > 30 kg/m2
Adults of American Society of Anesthesiologists’ physical status 3 or more
emergency surgery
foreigner  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome pain incidence at PACU (post anesthesia care unit) 
Timepoint at arrival and 30 minutes after PACU admission 
Secondary Outcome(s) 1 
Outcome incidence of administered analgesics due to pain NRS > 4 at PACU, PONV (postoperative nausea and vomiting) at PACU 
Timepoint at arrival and 30 minutes after PACU admission 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Yes 
Time of Sharing 2020.12
Way of Sharing Available on Request
(jlee0616@cha.ac.kr)
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