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

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Indiana University

Status

Terminated

Conditions

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

Treatments

Procedure: Serratus anterior block

Study type

Interventional

Funder types

Other

Identifiers

NCT04258436
1905162549

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

38 weeks to 12 months old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1 participants in 2 patient groups

Group 1-Block Arm
Active Comparator group
Description:
Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia
Treatment:
Procedure: Serratus anterior block
Group 2-No Block Arm
No Intervention group
Description:
Group 2 will not receive a serratus block after induction of general anesthesia

Trial contacts and locations

1

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Central trial contact

Anne E Cossu, MD

Data sourced from clinicaltrials.gov

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