- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949310
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
-
-
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
|
|
Experimental: Nefopam
Intraoperative use of nefopam 40 mg
|
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.
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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