48 Participants NeededMy employer runs this trial

PECS Block for Postoperative Pain in Children

KT
CP
Overseen ByCarolyne Pehora
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain after surgery for children receiving a Cardiac Implantable Electronic Device (CIED). It examines whether a pectoral nerve block (a technique to numb the chest area) can reduce the need for opioids post-surgery, compared to direct wound numbing. The study uses bupivacaine (a local anesthetic) combined with epinephrine to evaluate this technique. Children aged 3-18 undergoing CIED surgery on their chest are suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for the PECS block treatment?

Previous studies have shown that bupivacaine with epinephrine is generally well-tolerated for pectoral nerve blocks. These studies indicate that this treatment effectively reduces the need for opioids (strong painkillers) after surgery, demonstrating good pain management. However, reports of serious side effects, such as heart problems, have occurred, particularly if the dosage is not carefully controlled.

In this trial, researchers keep the dosage below the toxic limit to minimize the risk of these side effects. It is important to note that the FDA has already approved this medication for other uses, which generally supports its safety when used correctly. Overall, while risks exist, the treatment appears safe for most people when administered within the recommended limits.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the PECS block technique for managing postoperative pain in children because it offers a targeted approach to pain relief by delivering bupivacaine 0.25% with epinephrine directly to the fascial planes identified in PECS I and II. This method could potentially reduce the need for systemic pain medications, which often come with side effects. Unlike traditional methods that may involve higher doses or systemic administration, the PECS block uses a precise, localized delivery that minimizes exposure while effectively managing pain at the surgical site. This could lead to better pain management outcomes and faster recovery times for children undergoing surgery.

What evidence suggests that the PECS block could be effective for reducing postoperative pain in children undergoing CIED surgery?

This trial will compare the effectiveness of two postoperative pain management strategies in children: the PECS block and wound infiltration. Research has shown that pectoral nerve blocks with bupivacaine and epinephrine, as used in the PECS block arm of this trial, can reduce postoperative pain. Studies have found that patients receiving this treatment reported less pain and required fewer opioid painkillers. Specifically, one study noted that these nerve blocks reduced pain and opioid use in children after heart device surgeries. This suggests that the treatment can enhance recovery by better managing pain. Overall, using bupivacaine in this manner has been linked to improved pain control after surgery.16789

Who Is on the Research Team?

KT

Katherine Taylor

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo CIED implantation surgery with either PECS block or local infiltration for pain management

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative morphine consumption, pain severity, and adverse events

Up to 2 days
Continuous monitoring until discharge

Follow-up

Participants are monitored for safety and effectiveness after discharge

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bupivacaine 0.25% with epinephrine 1:200000

Trial Overview

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.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PECS blockExperimental Treatment1 Intervention
Group II: InfiltrationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Citations

Efficacy of Pectoral Nerve Block using Bupivacaine with or ...

As regards the postoperative pain scores, the pain was significantly lower in both Group B and Group M in comparison with Group C on admission to PCAU and after ...

Pectoral nerve blocks decrease postoperative pain and ...

Pectoralis nerve blocks reduce postoperative pain scores and lower total opioid usage after new transvenous ICD or PM placement in the pediatric population.

NCT04577690 | PECS Study for CIED Implantation Surgery

The anesthesiologist will administer bupivacaine 0.25% with epinephrine 1:200000 by PECS block after induction of anesthesia before surgical incision. The EP ...

Evaluation of Pectoral Nerve Blocks Type II (PEC II) for ...

The present study aims to investigate the real value of blocking of the chest wall in postoperative analgesia in this population. If successful, ...

Pectoral Nerve (PECs) block for postoperative analgesia-a ...

Conclusion: When compared to general anesthesia with systemic opioids, PECs block was associated with significantly better perioperative pain control. There are ...

Pectoral Nerve Blocks (PECs) for Cardiovascular ...

The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more ...

Parasternal Nerve Block Using Bupivacaine for ...

The investigators hypothesize that Bupivacaine, a parasternal nerve block administered in pediatric patients undergoing cardiac surgery will reduce the ...

Efficacy of pectoralis nerve blocks I & II with liposomal ... - PMC

A randomized study with thirty-six patients concluded that PECs blocks with LA do not seem to decrease perioperative narcotic requirements or ...

Nerve Blocks - Medical Clinical Policy Bulletins

This Clinical Policy Bulletin addresses nerve blocks. Medical Necessity Aetna considers the following nerve blocks medically necessary.