Effectiveness of Nefopam in Breast Cancer Surgery | NCT02949310

Studies
Effectiveness of Nefopam in Breast Cancer Surgery

NCT02949310

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jan 11, 2018Actual

Enrollment

88Estimated

Phase

Not Applicable

Conditions

Breast Neoplasm Malignant Primary

Interventions

Nefopam
Normal Saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Oct 26, 2016

First Submission Date that Met QC Criteria

Oct 28, 2016

First Posted Date

Oct 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2018

Last Update Posted Date

Jan 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyo-Seok Na, Clinical professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Placebo use instead of nefopam	Drug: Normal Saline
Nefopam	Experimental	Intraoperative use of nefopam 40 mg	Drug: Nefopam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nefopam	Drug		Nefopam
Normal Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change of numerical rating scale for postoperative pain		At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	463-707	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D009340	Nefopam
D000077330	Saline Solution

Ancestor Terms

ID	Term
D010079	Oxazocines
D001392	Azocines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided