CClinicalTrials.gg
CompletedNCT02827136Updated Dec 19, 2017

Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

An interventional study of Lidocaine patch and hypafix and hypafix in Gallbladder Diseases, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-12-19.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gallbladder Diseases

Browse trials for

03

In context

Gallbladder Diseases

91 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.

This study's enrollment of 63 is below the median of 84 across 59 interventional studies indexed under Gallbladder Diseases.

Browse Gallbladder Diseases studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Infection, trauma, or bleeding on shoulder
  • Allergy to lidocaine
  • Chronic pain
  • Renal dysfunction
  • Liver dysfunction
  • Seizure
  • History of shoulder surgery
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Patch group

    Lidocaine patch and Hypafix

    Drug: Lidocaine patch and hypafix

  • Placebo comparator
    Control group

    Just Hypafix

    Drug: hypafix

Interventions

  • DrugLidocaine patch and hypafix

    Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction

  • Drughypafix

    Appliance of hypafix on both shoulder tip after anesthetic induction

06

What researchers measure

Primary outcomes

  1. Shoulder pain score

    Time frame: Change from baseline shoulder pain score up to 24 hr after end of surgery

Secondary outcomes

  1. Total number of analgesics request on ward

    Time frame: Up to postoperative day 3

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
    Suwon, Seoum, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02827136
Lead sponsor
Ajou University School of Medicine
Responsible party
Ji Eun Kim (Assistant professor, Ajou University School of Medicine) — Principal investigator
First posted
Jul 11, 2016
Start date
Feb 8, 2017
Primary completion
Sep 27, 2017
Completion
Sep 27, 2017
Last update
Dec 19, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion