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Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

This study is currently recruiting participants.
Verified December 2011 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01485939
First received: November 28, 2011
Last updated: December 5, 2011
Last verified: December 2011
History of Changes

November 28, 2011
December 5, 2011
November 2011
March 2012   (final data collection date for primary outcome measure)
post operative pain after laparoscopic cholecystectomy [ Time Frame: post operative periods ] [ Designated as safety issue: No ]
We will measure intensity of pain(numeric rating scale)at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.
Same as current
Complete list of historical versions of study NCT01485939 on ClinicalTrials.gov Archive Site
pain controlled drug doses in postoperative periods. [ Time Frame: postoperative periods ] [ Designated as safety issue: No ]
We will measure doses of pain controlled drug(opioid, NSAIDS) at post operative 30 minutes, 1, 2, 4, 6, 12, 24, 48 hours.
Same as current
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Not Provided
 
Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy
Not Provided

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.
  • 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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Postoperative, Pain
  • Other: placebo patch applied
    Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.
  • Other: 5% lidocaine patch
    Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.
  • Placebo Comparator: placebo patch
    Intervention: Other: placebo patch applied
  • Active Comparator: lidocaine patch
    Intervention: Other: 5% lidocaine patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Eunjoo Choi, MD 82-31-787-6572 ejchoi7956@gmail.com
Korea, Republic of
 
NCT01485939
Laparo_cholecystectomy_lidotop
Not Provided
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP