← Back to Search

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative morphine consumption

Secondary outcome measures

Adverse events

Incidence of nausea/emesis postoperatively

Incidence of pruritus

+2 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,745 Total Patients Enrolled

1 Trials studying Postoperative Pain

54 Patients Enrolled for Postoperative Pain

Katherine TaylorPrincipal InvestigatorThe Hospital for Sick Children

2 Previous Clinical Trials

260 Total Patients Enrolled

Media Library

Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration Clinical Trial Eligibility Overview. Trial Name: NCT04577690 — Phase 4

Postoperative Pain Research Study Groups: PECS block, Infiltration

Postoperative Pain Clinical Trial 2023: Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration Highlights & Side Effects. Trial Name: NCT04577690 — Phase 4

Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577690 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for people below the age of twenty to partake in this clinical experiment?

"This medical trial only accepts patients aged 3 to 18. According to the official data, there are 152 enrolled studies for minors and 485 for adults over 65 years old."

Answered by AI

May I enrol in this research project?

"This investigation is searching for 48 participants with progeny aged between 3 and 18 years old. Eligibility criteria stipulate that all subjects must be going through chest CIED surgery within the specified age range."

Answered by AI

Are there other investigations that have explored the effects of Bupivacaine 0.25% with epinephrine 1:200000 in PECS block and wound infiltration?

"Currently, there are 126 active clinical trials exploring the efficacy of Bupivacaine 0.25% with epinephrine 1:200000 administered via PECS block and wound infiltration. Out of them, 23 medical studies have reached Phase 3 and 181 sites across the US are currently running these experiments. The greatest concentration of research is located in Philadelphia, Pennsylvania."

Answered by AI

Are there any available openings in this research project?

"Affirmative, the information on clinicaltrials.gov indicates that recruitment for this trial is in progress. This medical study was initially posted to the website on December 1st 2019 and its details were recently updated on December 16th 2021. The researchers are seeking 48 patients from a single location."

Answered by AI

What is the recruitment size for participants in this research project?

"Yes, the latest information on clinicaltrials.gov shows that this study is recruiting patients at present. It was initially posted in December of 2019 and most recently revised in December 2021; 48 individuals are needed from a single site to partake in this trial."

Answered by AI

Is the combination of Bupivacaine 0.25% and epinephrine 1:200000, when administered through PECS block or wound infiltration technique, sanctioned by the Food & Drug Administration?

"This Phase 4 treatment, Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration, was deemed safe as it has an assigned score of 3 on our safety scale."

Answered by AI

What are the common applications of Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration?

"Bupivacaine 0.25% with epinephrine 1:200000 through PECS block and wound infiltration is a frequently used treatment for unresponsive bradycardia and other autoimmune diseases such as pemphigus, pupil, and lupus erythematosus cell."

Answered by AI

Recent research and studies

SpringerPlusJournal

Pectoral Nerves (PECS) and Intercostal Nerve Block for Cardiac Resynchronization Therapy Device Implantation

Fujiwara, Atsushi, Nobuyasu Komasawa, and Toshiaki Minami. 2014. “Pectoral Nerves (PECS) and Intercostal Nerve Block for Cardiac Resynchronization Therapy Device Implantation”. Springerplus. Springer Science and Business Media LLC. doi:10.1186/2193-1801-3-409.

Annals of Cardiac AnaesthesiaJournal

Efficacy of Bilateral Pectoralis Nerve Block for Ultrafast Tracking and Postoperative Pain Management in Cardiac Surgery

Nagaraja, PS, KarthikNarendra Kumar, RavikumarNagashetty Kalyane, NaveenG Singh, Madhu Krishna, Balaji Babu, R Varadaraju, N Sathish, and N Manjunatha. 2018. “Efficacy of Bilateral Pectoralis Nerve Block for Ultrafast Tracking and Postoperative Pain Management in Cardiac Surgery”. Annals of Cardiac Anaesthesia. Medknow. doi:10.4103/aca.aca_15_18.

Journal of Clinical AnesthesiaJournal

Comparison of the Effects of Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Opioid Consumption and Pain Scores of Patients After Radical Mastectomy Surgery: A Prospective, Randomized, Controlled Trial

Altıparmak, Başak, Melike Korkmaz Toker, Ali İhsan Uysal, Mustafa Turan, and Semra Gümüş Demirbilek. 2019. “Comparison of the Effects of Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Opioid Consumption and Pain Scores of Patients After Radical Mastectomy Surgery: A Prospective, Randomized, Controlled Trial”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2018.10.040.

Regional Anesthesia and Pain MedicineJournal