NCT02949310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

October 26, 2016

Last Update Submit

January 9, 2018

Conditions

Breast Neoplasm Malignant Primary

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change of numerical rating scale for postoperative pain

    At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo use instead of nefopam

Drug: Normal Saline

Nefopam

EXPERIMENTAL

Intraoperative use of nefopam 40 mg

Drug: Nefopam

Interventions

NefopamDRUG
Nefopam
Normal SalineDRUG
Control

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total mastectomy
  • Modified radical mastectomy
  • Nipple-sparing mastectomy
  • American Society of Anesthesiologists physical status I or II
  • Postoperative use of intravenous patient-controlled analgesia

You may not qualify if:

  • Chronic analgesia medication
  • Pregnancy
  • Lactating women
  • Previous operation history due to breast cancer
  • Cooperation with other surgery
  • Contraindication of nefopam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Interventions

NefopamSaline Solution

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 31, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations

KR(1)