Back to resultsEffect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy
Primary Purpose
Gallbladder Diseases
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine patch and hypafix
hypafix
Sponsored by
About this trial
This is an interventional prevention trial for Gallbladder Diseases
Eligibility Criteria
Inclusion Criteria:
- Laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
- Infection, trauma, or bleeding on shoulder
- Allergy to lidocaine
- Chronic pain
- Renal dysfunction
- Liver dysfunction
- Seizure
- History of shoulder surgery
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patch group
Control group
Arm Description
Lidocaine patch and Hypafix
Just Hypafix
Outcomes
Primary Outcome Measures
Shoulder pain score
Secondary Outcome Measures
Total number of analgesics request on ward
Full Information
NCT ID
NCT02827136
First Posted
July 4, 2016
Last Updated
December 18, 2017
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02827136
Brief Title
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy
Official Title
Ajou University School of Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the effect of lidocaine patch on the shoulder pain score after end of surgery.
The secondary purpose of this study is to investigate the effect of lidocaine patch on the total number of analgesic request on ward.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patch group
Arm Type
Experimental
Arm Description
Lidocaine patch and Hypafix
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Just Hypafix
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch and hypafix
Intervention Description
Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction
Intervention Type
Drug
Intervention Name(s)
hypafix
Intervention Description
Appliance of hypafix on both shoulder tip after anesthetic induction
Primary Outcome Measure Information:
Title
Shoulder pain score
Time Frame
Change from baseline shoulder pain score up to 24 hr after end of surgery
Secondary Outcome Measure Information:
Title
Total number of analgesics request on ward
Time Frame
Up to postoperative day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
Infection, trauma, or bleeding on shoulder
Allergy to lidocaine
Chronic pain
Renal dysfunction
Liver dysfunction
Seizure
History of shoulder surgery
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
State/Province
Seoum
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy
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