Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

December 18, 2017 updated by: Ji Eun Kim, Ajou University School of Medicine

Ajou University School of Medicine

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patch group
Lidocaine patch and Hypafix
Drug: Lidocaine patch and hypafix
Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction
PLACEBO_COMPARATOR: Control group
Just Hypafix
Drug: hypafix
Appliance of hypafix on both shoulder tip after anesthetic induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shoulder pain score
Time Frame: Change from baseline shoulder pain score up to 24 hr after end of surgery
Change from baseline shoulder pain score up to 24 hr after end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of analgesics request on ward
Time Frame: Up to postoperative day 3
Up to postoperative day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2017

Primary Completion (ACTUAL)

September 27, 2017

Study Completion (ACTUAL)

September 27, 2017

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (ESTIMATE)

July 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-OBS-16-076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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