Lidocaine Patch for Postoperative Analgesia After Laparos... | NCT01485939

Studies
Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

NCT01485939

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 6, 2011Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Postoperative, Pain

Interventions

placebo patch applied
5% lidocaine patch

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 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Mar 2012Estimated

Completion Date

May 2012Estimated

First Submitted Date

Nov 28, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 6, 2011Estimated

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 5, 2011

Last Update Posted Date

Dec 6, 2011Estimated

Description Module

Brief Summary

The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy.

Detailed Description

The 5% lidocaine patch have been approved for the treatment of postherpetic neuralgia.
The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores, pain controlled drug(opioids, NSAID) in post operative period.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo patch	Placebo Comparator		Other: placebo patch applied
lidocaine patch	Active Comparator		Other: 5% lidocaine patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo patch applied	Other	Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.	placebo patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post operative pain after laparoscopic cholecystectomy	We will measure intensity of pain(numeric rating scale)at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.	post operative periods

Secondary Outcomes

Measure	Description	Time Frame
pain controlled drug doses in postoperative periods.	We will measure doses of pain controlled drug(opioid, NSAIDS) at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.	postoperative periods

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients of ASA Ⅰ-Ⅱ
aged 18~65
scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

patients with chronic pain
patients with taking regular analgesics
patients with allergy to ketorolac or lidocaine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eunjoo Choi, MD	Contact	82-31-787-6572		ejchoi7956@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national university Bundang hospital	Recruiting	Seongnam	Kyoung-ki-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

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Browse Branches

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