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Effectiveness of Nefopam in Breast Cancer Surgery

Primary Purpose

Breast Neoplasm Malignant Primary

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nefopam
Normal Saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm Malignant Primary

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Nefopam

Arm Description

Placebo use instead of nefopam

Intraoperative use of nefopam 40 mg

Outcomes

Primary Outcome Measures

Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device

Secondary Outcome Measures

Change of numerical rating scale for postoperative pain

Full Information

First Posted
October 26, 2016
Last Updated
January 9, 2018
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02949310
Brief Title
Effectiveness of Nefopam in Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Malignant Primary

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo use instead of nefopam
Arm Title
Nefopam
Arm Type
Experimental
Arm Description
Intraoperative use of nefopam 40 mg
Intervention Type
Drug
Intervention Name(s)
Nefopam
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Seok Na
Phone
1087012913
Email
hsknana@gmail.com

12. IPD Sharing Statement

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Effectiveness of Nefopam in Breast Cancer Surgery

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