Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

Pain, Postoperative Clinical Trial

— SAPB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04258436
• Other study ID #: 1905162549
• Status: Terminated
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: June 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 38 Weeks to 12 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Postoperative Narcotic Exposure	Total morphine equivalents in first 24 hours	From start of anesthesia to 24 hours postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	Complications from the block, anesthesia or the surgery up to 72 hours post operatively	From block placement until 72 hours post operatively