Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

Not Applicable

Terminated

• Conditions: Opioid Use; Local Anaesthetic Agent Overdose; Local Anesthetic Complication; Pain, Postoperative; Post-thoracotomy Pain Syndrome
• Interventions: Procedure: Serratus anterior block

• Registration Number: NCT04258436
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-30
• Study Start: 2019-12-09
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1-Block Arm	Serratus anterior block	Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
Measurement of Postoperative Narcotic Exposure	From start of anesthesia to 24 hours postoperatively	Total morphine equivalents in first 24 hours

Secondary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation	From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days	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
Adverse events	From block placement until 72 hours post operatively	Complications from the block, anesthesia or the surgery up to 72 hours post operatively
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	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
Length of Cardiovascular ICU stay	From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days	Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days
Postoperative Pain Scores	From arrival to ICU to 24 hours postoperatively	Pain scores reported at arrival to ICU, and at 1, 2, 4, 6,8,10,12,and 24 hours

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States