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Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Seoul National University Hospital.
Recruitment status was:  Recruiting
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
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 ]
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
No Changes Posted
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.
Same as current
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01485939
Laparo_cholecystectomy_lidotop
Not Provided
Not Provided
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