Erector Spinae Plane Block With Two Different Volume for... | NCT04989933

Studies
Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery

NCT04989933

Sponsor

Ataturk University

Status

Unknown status

Last Update Posted

Aug 4, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sternotomy Pain

Interventions

Ultrasound-guided erector spinae plane block

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

ID	Type	Description	Link
Asli Demir	Other Identifier	Ankara City Hospital
Ali Ahiskalioglu	Other Identifier	Ataturk University

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2021Estimated

Primary Completion Date

Nov 1, 2021Estimated

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Jul 31, 2021

First Submission Date that Met QC Criteria

Jul 31, 2021

First Posted Date

Aug 4, 2021Actual

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

Jul 31, 2021

Last Update Posted Date

Aug 4, 2021Actual

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

The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.

This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy 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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESP 20 ml	Active Comparator	Ultrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine	Procedure: Ultrasound-guided erector spinae plane block
ESP 30 ml	Active Comparator	Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine	Procedure: Ultrasound-guided erector spinae plane block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound-guided erector spinae plane block	Procedure	Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine	ESP 20 ml ESP 30 ml

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rescue analgesia	Total amount of rescue analgesic	Post-extubation 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery

Exclusion Criteria:

chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided