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

Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Opioid Use; Local Anesthetic Complication; Post-thoracotomy Pain Syndrome; Local Anaesthetic Agent Overdose
• Intervention / Treatment: Procedure: Serratus anterior block

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital For Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1-Block Arm; Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia	Procedure: Serratus anterior block; Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine
No Intervention: Group 2-No Block Arm; Group 2 will not receive a serratus block after induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days	From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU 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	From arrival to ICU to 24 hours postoperatively
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	From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days
Adverse events	Complications from the block, anesthesia or the surgery up to 72 hours post operatively	From block placement until 72 hours post operatively

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Anne E Cossu, MD, Indiana University Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Post thoractomy pain; Fascial plane blocks; Early recovery after thoractomy; Serratus anterior fascial block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 1905162549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No