Effectiveness of Nefopam in Breast Cancer Surgery

Seoul National University

Status: Unknown

Conditions: Breast Neoplasm Malignant Primary

Treatments: Drug: Nefopam; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02949310

Nefo-TM & MRM

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo use instead of nefopam

Treatment:

Drug: Normal Saline

Nefopam

Experimental group

Description:

Intraoperative use of nefopam 40 mg

Treatment:

Drug: Nefopam