Effectiveness of Nefopam in Breast Cancer Surgery

January 9, 2018 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

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, 463-707
        • Recruiting
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Total mastectomy
  • Modified radical mastectomy
  • Nipple-sparing mastectomy
  • American Society of Anesthesiologists physical status I or II
  • Postoperative use of intravenous patient-controlled analgesia

Exclusion Criteria:

  • Chronic analgesia medication
  • Pregnancy
  • Lactating women
  • Previous operation history due to breast cancer
  • Cooperation with other surgery
  • Contraindication of nefopam

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo use instead of nefopam
Drug: Normal Saline
Experimental: Nefopam
Intraoperative use of nefopam 40 mg
Drug: Nefopam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device
Time Frame: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of numerical rating scale for postoperative pain
Time Frame: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month

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 (Actual)

October 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nefo-TM & MRM

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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