NCT02827136CompletedNot Applicable
Ajou University School of Medicine
Ajou University School of Medicine1 site in 1 country63 target enrollmentStarted: February 8, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Shoulder pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria
- •Infection, trauma, or bleeding on shoulder
- •Allergy to lidocaine
- •Chronic pain
- •Renal dysfunction
- •Liver dysfunction
- •History of shoulder surgery
Arms & Interventions
Patch group
Experimental
Lidocaine patch and Hypafix
Intervention: Lidocaine patch and hypafix (Drug)
Control group
Placebo Comparator
Just Hypafix
Intervention: hypafix (Drug)
Outcomes
Primary Outcomes
Shoulder pain score
Time Frame: Change from baseline shoulder pain score up to 24 hr after end of surgery
Secondary Outcomes
- Total number of analgesics request on ward(Up to postoperative day 3)
Investigators
Ji Eun Kim
Assistant professor
Ajou University School of Medicine
Study Sites (1)
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