The Preemptive Analgesic Efficacy of Nefopam

Breast Neoplasm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561468
• Other study ID #: Nefo_breast cancer
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: April 5, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• Nefopam

• Saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of pain numerical rating score from postoperative 30 min until postoperative 3 month		Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month	No
Secondary	The dose of ketorolac administered to the patient.		postoperative 1 day	No