Serratus Anterior Plane Block for Management of Post Thor... | NCT04258436

Studies
Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

NCT04258436

Sponsor

Indiana University

Status

Terminated

Last Update Posted

Jun 18, 2023Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Opioid Use
Post-thoracotomy Pain Syndrome
Local Anaesthetic Agent Overdose
Local Anesthetic Complication
Pain, Postoperative

Interventions

Serratus anterior block

Countries

United States

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

I believe 1 patient was enrolled. The original PI left the institution and the study was not continued after her departure.

Expanded Access Info

Start Date

Dec 9, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Aug 30, 2019

First Submission Date that Met QC Criteria

Feb 4, 2020

First Posted Date

Feb 6, 2020Actual

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

Jun 14, 2023

Last Update Posted Date

Jun 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rania K. Abbasi, Associate Professor of Clinical Anesthesia, Indiana UniversityPrincipal Investigator

Lead Sponsor

Indiana UniversityOTHER

Collaborators

Not provided

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

This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.

Detailed Description

This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management.

Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution.

Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block.

Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.

Conditions Module

Conditions

Opioid Use
Post-thoracotomy Pain Syndrome
Local Anaesthetic Agent Overdose
Local Anesthetic Complication
Pain, Postoperative

Keywords

Post thoractomy pain
Fascial plane blocks
Early recovery after thoractomy
Serratus anterior fascial block

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1-Block Arm	Active Comparator	Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia	Procedure: Serratus anterior block
Group 2-No Block Arm	No Intervention	Group 2 will not receive a serratus block after induction of general anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serratus anterior block	Procedure	Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine	Group 1-Block Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of Postoperative Narcotic Exposure	Total morphine equivalents in first 24 hours	From start of anesthesia to 24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Duration of Mechanical Ventilation	Total Time in hours and minutes of endotracheal intubation from date and time of intubation to the date and time of extubation up to 100 days	From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days
Length of Cardiovascular ICU stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12 months of age or less
Infants undergoing cardiac surgery through a thoracotomy incision
Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital

Exclusion Criteria:

Infants requiring sternotomy or emergency surgery
Allergy to local anesthetics
Neonates less that 37 weeks gestation
Infants intubated prior to surgery
Infection at the site of the Serratus Anterior Plane Block 6. Bleeding diathesis with increased risk of hematoma at the block site 7. Allergy to morphine 8. Active pulmonary infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Weeks

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne E Cossu, MD	Indiana University Department of Anesthesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Riley Hospital for Children		Indianapolis	Indiana	46202	United States

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

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