Effectiveness of Nefopam in Breast Cancer Surgery

NCT ID: NCT02949310

Last Updated: 2018-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasm Malignant Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Placebo use instead of nefopam

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Nefopam

Intraoperative use of nefopam 40 mg

Group Type EXPERIMENTAL

Nefopam

Intervention Type DRUG

Interventions

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Nefopam

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Hyo-Seok Na

Role: primary

1087012913

Other Identifiers

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Nefo-TM & MRM

Identifier Type: -

Identifier Source: org_study_id

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