Back to resultsThe Preemptive Analgesic Efficacy of Nefopam
Primary Purpose
Breast Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nefopam
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasm
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nefopam
Control
Arm Description
20 mg nefopam in 100 ml normal saline is infused before starting operation.
100 ml normal saline is infused before starting operation.
Outcomes
Primary Outcome Measures
The change of pain numerical rating score from postoperative 30 min until postoperative 3 month
Secondary Outcome Measures
The dose of ketorolac administered to the patient.
Full Information
NCT ID
NCT02561468
First Posted
August 3, 2015
Last Updated
April 5, 2016
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02561468
Brief Title
The Preemptive Analgesic Efficacy of Nefopam
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nefopam
Arm Type
Experimental
Arm Description
20 mg nefopam in 100 ml normal saline is infused before starting operation.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
100 ml normal saline is infused before starting operation.
Intervention Type
Drug
Intervention Name(s)
Nefopam
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The dose of ketorolac administered to the patient.
Time Frame
postoperative 1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
443-607
Country
Korea, Republic of
12. IPD Sharing Statement
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The Preemptive Analgesic Efficacy of Nefopam
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