Serratus Anterior Plane Block for Management of Post Thoracotomy Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2021-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Pediatric Cardiovascular ICU personnel will be blinded to the randomization assignment

Study Groups

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Group 1-Block Arm

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

Group Type ACTIVE_COMPARATOR

Serratus anterior block

Intervention Type PROCEDURE

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

Group 2-No Block Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Serratus anterior block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

38 Weeks

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No