Effectiveness of Nefopam in Breast Cancer Surgery

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02949310

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 efficacy on acute and chronic postoperative pain.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Malignant Primary	Drug: Nefopam Drug: Normal Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Placebo use instead of nefopam	Drug: Normal Saline
Experimental: Nefopam Intraoperative use of nefopam 40 mg	Drug: Nefopam

Arm

Intervention/Treatment

Placebo Comparator: Control

Placebo use instead of nefopam

Drug: Normal Saline

Experimental: Nefopam

Intraoperative use of nefopam 40 mg

Drug: Nefopam

Outcome Measures

Primary Outcome Measures

Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device [At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month]

Secondary Outcome Measures

Change of numerical rating scale for postoperative pain [At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyo-Seok Na, Clinical professor, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT02949310

Other Study ID Numbers:

Nefo-TM & MRM

First Posted:

Oct 31, 2016

Last Update Posted:

Jan 11, 2018

Last Verified:

Jan 1, 2018

Additional relevant MeSH terms:

Breast Neoplasms

Neoplasms

Nefopam

Study Results

No Results Posted as of Jan 11, 2018