Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative, Pain
• Intervention / Treatment: Other: placebo patch applied; Other: 5% lidocaine patch

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyoung-ki-do
    • Seongnam, Kyoung-ki-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain controlled drug doses in 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.	postoperative periods

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: lidocaine patch; laparoscopic cholecystectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Laparo_cholecystectomy_lidotop

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No