NCT02561468

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

August 3, 2015

Last Update Submit

April 5, 2016

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The dose of ketorolac administered to the patient.

    postoperative 1 day

Study Arms (2)

Nefopam

EXPERIMENTAL

20 mg nefopam in 100 ml normal saline is infused before starting operation.

Drug: Nefopam

Control

PLACEBO COMPARATOR

100 ml normal saline is infused before starting operation.

Drug: Saline

Interventions

NefopamDRUG
Nefopam
SalineDRUG
Control

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal
  • Seizure
  • Cardiac disease
  • Monoamine oxidase inhibitor user
  • Urologic disease
  • Glucoma
  • Preoperative analgesic drug medication
  • Pregnancy
  • Recurred breast cancer patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 443-607, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

NefopamSodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 3, 2015

First Posted

September 28, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

KR(1)