Sensorial Block Assessment of Erector Spinae Block | NCT03744520

Studies
Sensorial Block Assessment of Erector Spinae Block

NCT03744520

Sponsor

Onur Selvi

Status

Completed

Last Update Posted

Oct 4, 2019Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Regional Anesthesia Morbidity

Interventions

Erector spinae plane block

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

Oct 2019

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

Nov 15, 2018Actual

Primary Completion Date

Oct 3, 2019Actual

Completion Date

Oct 3, 2019Actual

First Submitted Date

Oct 25, 2018

First Submission Date that Met QC Criteria

Nov 14, 2018

First Posted Date

Nov 16, 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

Oct 3, 2019

Last Update Posted Date

Oct 4, 2019Actual

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

Ultrasound-guided erector spinae plane blocks are used as postoperative analgesia method for abdominal, chest and hip surgeries. Regional techniques are well-described methods for postoperative analgesia. However, the sensorial dermatomal spread of regional block varies depending on the multiple variables as the level of the block, local analgesic concentration etc. The aim of this study is to observe dermatomal evaluation of sensorial block.

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
ESP block group	Experimental	The patients who had paravertebral interfacial plane block for postoperative analgesia	Procedure: Erector spinae plane block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Procedure	Local anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process.	ESP block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spread of sensorial block	The sensorial block will be evaluated with dermatomal examination	in postoperative sixth hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who received successful erector spinae plane block for postoperative analgesia

Exclusion Criteria:

Patients under 18 years old
Patients who are not able to communicate with
Patients who are on medication which may change the perception of pain.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Maltepe University Medical Faculty		Istanbul	Maltepe	34843	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