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PECS Block for Postoperative Pain in Children

Phase 4

Recruiting

Led By Katherine Taylor

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 hours, 6 hours, 12 hours and at discharge from hospital

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the amount of pain medication needed by children who receive a pectoral nerve block before surgery to those who receive local anesthesia alone.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or swelling, low blood pressure due to epinephrine, and rare but serious complications such as seizures or heart problems from bupivacaine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 hours, 6 hours, 12 hours and at discharge from hospital

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 hours, 6 hours, 12 hours and at discharge from hospital

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 hours, 6 hours, 12 hours and at discharge from hospital for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative morphine consumption

Secondary study objectives

Adverse events

Incidence of nausea/emesis postoperatively

Incidence of pruritus

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

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