The Effect of Double Injection Erector Spinae Plane Block... | NCT03415646

Studies
The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery

NCT03415646

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Mar 9, 2018Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Postoperative Pain
Breast Cancer

Interventions

Erector Spinae Plane Block
Intravenous Morphine patient controlled analgesia device

Countries

Turkey (Türkiye)

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2018Actual

Primary Completion Date

Mar 5, 2018Actual

Completion Date

Mar 7, 2018Actual

First Submitted Date

Jan 10, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 30, 2018Actual

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

Mar 7, 2018

Last Update Posted Date

Mar 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Block Group	Active Comparator	Erector Spinae Plane Block administered group	Other: Erector Spinae Plane Block Device: Intravenous Morphine patient controlled analgesia device
Control Group	Sham Comparator	Control group	Device: Intravenous Morphine patient controlled analgesia device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector Spinae Plane Block	Other	erector spinae plane block with double level injection will be administered before the surgery	Block Group

Measure	Description	Time Frame
Morphine consumption		24 hour postoperatively

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

25-70 years of age
ASA I-II
Undergoing elective breast cancer surgery

Exclusion Criteria:

obesity (body mass index >35 kg/m2)
infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
recent use of analgesic drugs.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

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
Kocaeli University Hospital		İzmit	Kocaeli	41340	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided