Breast Neoplasm Malignant PrimaryNCT02949310
Effectiveness of Nefopam in Breast Cancer Surgery
A study testing Nefopam and Normal Saline in people with Breast Neoplasm Malignant Primary, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasm Malignant Primary
- What is being tested?
- Nefopam and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total mastectomy
- Modified radical mastectomy
- Nipple-sparing mastectomy
- American Society of Anesthesiologists physical status I or II
- Postoperative use of intravenous patient-controlled analgesia
Who cannot join
- Chronic analgesia medication
- Pregnancy
- Lactating women
- Previous operation history due to breast cancer
- Cooperation with other surgery
- Contraindication of nefopam
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyo-Seok Na, 1087012913, hsknana@gmail.com
About this study
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.
- Conditions
- Breast Neoplasm Malignant Primary
- Being tested
- Nefopam, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo use instead of nefopam Receives: Drug: Normal Saline |
| Nefopam | Experimental | Intraoperative use of nefopam 40 mg Receives: Drug: Nefopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device
Measured: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
Secondary outcomes (1)
Change of numerical rating scale for postoperative pain
Measured: At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm Malignant PrimaryStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949310
- Sponsor's protocol ID
- Nefo-TM & MRM
- Status last verified
- Jan 2018
- First submitted
- 26 Oct 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nefopam in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02949310
- Acronym / sponsor ID
- Nefo-TM & MRM
- Conditions
- Breast Neoplasm Malignant Primary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal SalinePlacebo use instead of nefopam |
| Nefopam | Experimental | Drug: NefopamIntraoperative use of nefopam 40 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Total mastectomy
- Modified radical mastectomy
- Nipple-sparing mastectomy
- American Society of Anesthesiologists physical status I or II
- Postoperative use of intravenous patient-controlled analgesia
Key exclusion criteria (6 listed)
- Chronic analgesia medication
- Pregnancy
- Lactating women
- Previous operation history due to breast cancer
- Cooperation with other surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nefopam | Drug | Nefopam |
| Normal Saline | Drug | Control |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
Related trials for Breast Neoplasm Malignant Primary
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nefopam and Normal Saline in people with Breast Neoplasm Malignant Primary, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.