Effect of Lidocaine Patch for Shoulder Pain in Laparoscop... | NCT02827136

Studies
Effect of Lidocaine Patch for Shoulder Pain in Laparoscopic Cholecystectomy

NCT02827136

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Dec 19, 2017Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Gallbladder Diseases

Interventions

Lidocaine patch and hypafix
hypafix

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2017Actual

Primary Completion Date

Sep 27, 2017Actual

Completion Date

Sep 27, 2017Actual

First Submitted Date

Jul 4, 2016

First Submission Date that Met QC Criteria

Jul 7, 2016

First Posted Date

Jul 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2017

Last Update Posted Date

Dec 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ji Eun Kim, Assistant professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patch group	Experimental	Lidocaine patch and Hypafix	Drug: Lidocaine patch and hypafix
Control group	Placebo Comparator	Just Hypafix	Drug: hypafix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine patch and hypafix	Drug	Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction	Patch group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine		Suwon	Seoum		South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005705	Gallbladder Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C113018	hypafix

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided