PECS Block for Postoperative Pain in Children

Recruiting in Palo Alto (17 mi)

Overseen byKatherine Taylor

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: The Hospital for Sick Children

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.

Eligibility Criteria

This trial is for children and adolescents aged 3-18 who are undergoing surgery to place a cardiac device. They must not be allergic to bupivacaine, pregnant, breastfeeding, or have any condition that could affect study participation as judged by the lead researcher.

Inclusion Criteria

Children and teenagers having surgery for a device placed in their chest.

Exclusion Criteria

Pregnancy or lactation

No parental or patient consent

Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.

+2 more

Participant Groups

The study is testing if using a pectoral nerve block (PECS) with bupivacaine and epinephrine before chest surgery can reduce opioid use after the operation compared to just local anesthesia at the wound site.

2Treatment groups

Experimental Treatment

Active Control

Group I: PECS blockExperimental Treatment1 Intervention

A PECS block of 0.25 % bupivacaine with epinephrine 1:200000 (below the toxic dose limit of 3 mg/kg) in divided doses to cover the fascial planes identified in PECS I and PECS II. At the completion of surgery, the wound will be infiltrated with up to 0.2 ml/kg of 0.25 % bupivacaine into the wound.

Group II: InfiltrationActive Control1 Intervention

At the completion of surgery, the EP cardiologist will infiltrate the wound with up to 0.8 ml/kg of 0.25 % bupivacaine with epinephrine 1:200000.