Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy
This study is currently recruiting participants.
Verified December 2011 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
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
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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
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 |
ClinicalTrials.gov processed this record on June 17, 2013