Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy

Postoperative, Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01485939
• Other study ID #: Laparo_cholecystectomy_lidotop
• Status: Recruiting
• Phase: Phase 4
• First received: November 28, 2011
• Last updated: December 5, 2011
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2011
• Source: Seoul National University Hospital
• Contact: Eunjoo Choi, MD
• Phone: 82-31-787-6572
• Email: ejchoi7956[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients of ASA ?-?

• 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 Design

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

Related Conditions & MeSH terms

• Postoperative, Pain

Intervention

Other:
• placebo patch applied
Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.
• 5% lidocaine patch
Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university Bundang hospital	Seongnam	Kyoung-ki-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No