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Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

NCT ID: NCT02827136

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-08

Study Completion Date

2017-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Gallbladder Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patch group

Lidocaine patch and Hypafix

Group Type EXPERIMENTAL

Lidocaine patch and hypafix

Intervention Type DRUG

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

Control group

Just Hypafix

Group Type PLACEBO_COMPARATOR

hypafix

Intervention Type DRUG

Appliance of hypafix on both shoulder tip after anesthetic induction

Interventions

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Lidocaine patch and hypafix

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

Intervention Type DRUG

hypafix

Appliance of hypafix on both shoulder tip after anesthetic induction

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ji Eun Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-OBS-16-076

Identifier Type: -

Identifier Source: org_study_id