Effectiveness of Nefopam in Breast Cancer Surgery

Seoul National University Bundang Hospital88 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Breast Neoplasm Malignant Primary

Interventions

NefopamDRUG

Normal SalineDRUG

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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