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Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

NCT ID: NCT01485939

Last Updated: 2011-12-06

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

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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

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* 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.

Conditions

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Postoperative, Pain

Keywords

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lidocaine patch laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo patch

Group Type PLACEBO_COMPARATOR

placebo patch applied

Intervention Type OTHER

Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.

lidocaine patch

Group Type ACTIVE_COMPARATOR

5% lidocaine patch

Intervention Type OTHER

Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.

Interventions

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placebo patch applied

Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.

Intervention Type OTHER

5% lidocaine patch

Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul national university Bundang hospital

Seongnam, Kyoung-ki-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Eunjoo Choi, MD

Role: CONTACT

Phone: 82-31-787-6572

Email: [email protected]

Facility Contacts

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Eunjoo Choi, MD

Role: primary

Other Identifiers

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Laparo_cholecystectomy_lidotop

Identifier Type: -

Identifier Source: org_study_id