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Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01485939
Recruitment Status : Unknown
Verified December 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Postoperative, Pain Other: placebo patch applied Other: 5% lidocaine patch Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : November 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo patch Other: placebo patch applied
Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.
Active Comparator: lidocaine patch Other: 5% lidocaine patch
Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.


Outcome Measures

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


Secondary Outcome Measures :
  1. pain controlled drug doses in postoperative periods. [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485939


Contacts
Contact: Eunjoo Choi, MD 82-31-787-6572 ejchoi7956@gmail.com

Locations
Korea, Republic of
Seoul national university Bundang hospital Recruiting
Seongnam, Kyoung-ki-do, Korea, Republic of, 463-707
Contact: Eunjoo Choi, MD    82-31-787-6572    ejchoi7956@gmail.com   
Principal Investigator: Pyung Bok Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01485939     History of Changes
Other Study ID Numbers: Laparo_cholecystectomy_lidotop
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by Seoul National University Hospital:
lidocaine patch
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action