Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
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
  Purpose

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 Intervention Phase
Postoperative, Pain
Other: placebo patch applied
Other: 5% lidocaine patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01485939     History of Changes
Other Study ID Numbers: Laparo_cholecystectomy_lidotop
Study First Received: November 28, 2011
Last Updated: December 5, 2011
Health Authority: Korea: Institutional Review Board

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014