NCT01485939

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

November 28, 2011

Last Update Submit

December 5, 2011

Conditions

Postoperative, Pain

Keywords

lidocaine patchlaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pain controlled drug doses in postoperative periods.

    postoperative periods

Study Arms (2)

placebo patch

PLACEBO COMPARATOR
Other: placebo patch applied

lidocaine patch

ACTIVE COMPARATOR
Other: 5% lidocaine patch

Interventions

placebo patch appliedOTHER

Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.

placebo patch
5% lidocaine patchOTHER

Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.

lidocaine patch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of ASA Ⅰ-Ⅱ
  • aged 18\~65
  • scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

  • patients with chronic pain
  • patients with taking regular analgesics
  • patients with allergy to ketorolac or lidocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university Bundang hospital

Seongnam, Kyoung-ki-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Eunjoo Choi, MD

CONTACT

82-31-787-6572ejchoi7956@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 6, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

KR(1)