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Serratus Anterior Plane Block for Management of Post Thoracotomy Pain (SAPB)

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serratus anterior block
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid Use focused on measuring Post thoractomy pain, Fascial plane blocks, Early recovery after thoractomy, Serratus anterior fascial block

Eligibility Criteria

38 Weeks - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riley Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1-Block Arm

Group 2-No Block Arm

Arm Description

Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia

Group 2 will not receive a serratus block after induction of general anesthesia

Outcomes

Primary Outcome Measures

Measurement of Postoperative Narcotic Exposure
Total morphine equivalents in first 24 hours

Secondary Outcome Measures

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
Length of Cardiovascular ICU stay
Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days
Postoperative Pain Scores
Pain scores reported at arrival to ICU, and at 1, 2, 4, 6,8,10,12,and 24 hours
Duration of Supplemental oxygen exposure
Total time of supplemental oxygen usage from date and time of endotracheal extubation and application of supplemental oxygen to date and time of supplemental oxygen discontinuation up to 100 days
Adverse events
Complications from the block, anesthesia or the surgery up to 72 hours post operatively

Full Information

First Posted
August 30, 2019
Last Updated
June 14, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04258436
Brief Title
Serratus Anterior Plane Block for Management of Post Thoracotomy Pain
Acronym
SAPB
Official Title
Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
I believe 1 patient was enrolled. The original PI left the institution and the study was not continued after her departure.
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Pediatric Cardiovascular ICU personnel will be blinded to the randomization assignment
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1-Block Arm
Arm Type
Active Comparator
Arm Description
Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia
Arm Title
Group 2-No Block Arm
Arm Type
No Intervention
Arm Description
Group 2 will not receive a serratus block after induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior block
Intervention Description
Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine
Primary Outcome Measure Information:
Title
Measurement of Postoperative Narcotic Exposure
Description
Total morphine equivalents in first 24 hours
Time Frame
From start of anesthesia to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Duration of Mechanical Ventilation
Description
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
Time Frame
From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days
Title
Length of Cardiovascular ICU stay
Description
Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days
Time Frame
From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days
Title
Postoperative Pain Scores
Description
Pain scores reported at arrival to ICU, and at 1, 2, 4, 6,8,10,12,and 24 hours
Time Frame
From arrival to ICU to 24 hours postoperatively
Title
Duration of Supplemental oxygen exposure
Description
Total time of supplemental oxygen usage from date and time of endotracheal extubation and application of supplemental oxygen to date and time of supplemental oxygen discontinuation up to 100 days
Time Frame
From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days
Title
Adverse events
Description
Complications from the block, anesthesia or the surgery up to 72 hours post operatively
Time Frame
From block placement until 72 hours post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne E Cossu, MD
Organizational Affiliation
Indiana University Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

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