The Preemptive Analgesic Efficacy of Nefopam

April 5, 2016 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 443-607
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients diagnosed with breast cancer
  • Lumpectomy with axillary lymph node dissection or Lumpectomy with sentinel lymph node biopsy
  • American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

  • Refusal
  • Seizure
  • Cardiac disease
  • Monoamine oxidase inhibitor user
  • Urologic disease
  • Glucoma
  • Preoperative analgesic drug medication
  • Pregnancy
  • Recurred breast cancer patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nefopam
20 mg nefopam in 100 ml normal saline is infused before starting operation.
Drug: Nefopam
Placebo Comparator: Control
100 ml normal saline is infused before starting operation.
Drug: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of pain numerical rating score from postoperative 30 min until postoperative 3 month
Time Frame: Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month
Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
The dose of ketorolac administered to the patient.
Time Frame: postoperative 1 day
postoperative 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nefo_breast cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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