NCT04258436

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

August 30, 2019

Last Update Submit

June 14, 2023

Conditions

Opioid UsePost-thoracotomy Pain SyndromeLocal Anaesthetic Agent OverdoseLocal Anesthetic ComplicationPain, Postoperative

Keywords

Post thoractomy painFascial plane blocksEarly recovery after thoractomySerratus anterior fascial block

Outcome Measures

Primary Outcomes (1)

  • Measurement of Postoperative Narcotic Exposure

    Total morphine equivalents in first 24 hours

    From start of anesthesia to 24 hours postoperatively

Secondary Outcomes (5)

  • Duration of Mechanical Ventilation

    From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days

  • Length of Cardiovascular ICU stay

    From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days

  • Postoperative Pain Scores

    From arrival to ICU to 24 hours postoperatively

  • Duration of Supplemental oxygen exposure

    From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days

  • Adverse events

    From block placement until 72 hours post operatively

Study Arms (2)

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

Serratus anterior blockPROCEDURE

Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine

Group 1-Block Arm

Eligibility Criteria

Age38 Weeks - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Anne E Cossu, MD

    Indiana University Department of Anesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Pediatric Cardiovascular ICU personnel will be blinded to the randomization assignment
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Anesthesia

Study Record Dates

First Submitted

August 30, 2019

First Posted

February 6, 2020

Study Start

December 9, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)