Effects of Regional Anesthesia Following Mastectomy | NCT05276440

Studies
Effects of Regional Anesthesia Following Mastectomy

NCT05276440

Sponsor

Koc University Hospital

Status

Completed

Last Update Posted

Mar 11, 2022Actual

Enrollment

182Actual

Phase

Not provided

Conditions

Postoperative Pain

Interventions

Not provided

Countries

Not provided

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 2022

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

Apr 1, 2016Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Feb 19, 2022

First Submission Date that Met QC Criteria

Mar 2, 2022

First Posted Date

Mar 11, 2022Actual

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 2, 2022

Last Update Posted Date

Mar 11, 2022Actual

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

Patients of breast surgery dated between April 2016 and March 2021 will be scanned in three groups; solely induced general anesthesia, general anesthesia induced with Erector Spinae Plane Block, and general anesthesia induced with Rhomboid Block.

The investigators aimed to retrospectively compare the effectiveness of regional anesthesia techniques used in the clinic for postoperative recovery and opioid consumption in patients who underwent breast surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

182Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total opioid consumption retrieved from the patient records		up to 24 hours
Length of hospital stay		up to 1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent breast surgery under general anesthesia with or without one of the blocks; Erector Spinae Plane Block and Rhomboid Block.

Exclusion Criteria:

Incomplete patient forms.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Breast surgery patients

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

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