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Procedure

Postoperative Pain Management for Pectus Excavatum ((MIRPE) Trial)

N/A
Recruiting
Research Sponsored by University of Colorado, Denver
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 24 months
Awards & highlights

(MIRPE) Trial Summary

This trial aims to compare the three most commonly used methods for managing postoperative pain in patients who have had minimally invasive repair of pectus excavatum (MIRPE).

Who is the study for?
This trial is for children and teenagers aged 13-18 with a chest wall deformity called pectus excavatum who are scheduled for minimally invasive repair surgery. It's not open to those who've had previous chest surgeries, pectus repairs, are pregnant, or use narcotics regularly.Check my eligibility
What is being tested?
The study tests three pain control methods after chest wall correction surgery: patient-controlled analgesia (PCA), erector spinae blocks (ESB) with pumps, and video-assisted intercostal nerve cryoablation (INC). The goal is to find the most effective postoperative pain relief.See study design
What are the potential side effects?
Potential side effects from these pain management methods may include nausea, itching from medication in PCA; discomfort or infection at infusion sites for ESB; and localized numbness or skin changes due to INC.

(MIRPE) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of Stay
Secondary outcome measures
Complications
Postoperative pain
Quality of life after MIRPE
+1 more

(MIRPE) Trial Design

3Treatment groups
Experimental Treatment
Group I: Patient Controlled AnalgesiaExperimental Treatment1 Intervention
This technique involves connecting a patient controlled analgesia pump to the intravenous line. The patient has the ability to push a button to obtain a predetermined dose of an intravenous opioid with a set lockout time period to minimize the potential for over sedation. PCA pumps will be connected to the intravenous line of the patient at the end of the MIRPE operation. anesthesiologists with experience in regional anesthesia.
Group II: Intercostal Nerve CryoablationExperimental Treatment1 Intervention
The INC technique relies on multilevel freezing of the intercostal neurovascular bundle intraoperatively to block sensation and pain for approximately 2 months postoperatively. Trained pediatric surgeons will perform the INC at the time of a MIRPE procedure.
Group III: Erector Spinae BlockExperimental Treatment1 Intervention
This method consists of the anesthesiologist placing two catheters on each side of the vertebrae which then delivers pain medicine continuously via pumps for 2-3 days post-surgery.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,368 Total Patients Enrolled
1 Trials studying Postoperative Pain
58 Patients Enrolled for Postoperative Pain
Children's Hospital ColoradoOTHER
116 Previous Clinical Trials
5,132,657 Total Patients Enrolled
Natasha Corbitt, MDStudy DirectorSafety Officer--University of Texas Southwestern

Media Library

MIRPE (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04211935 — N/A
Postoperative Pain Research Study Groups: Intercostal Nerve Cryoablation, Patient Controlled Analgesia, Erector Spinae Block
Postoperative Pain Clinical Trial 2023: MIRPE Highlights & Side Effects. Trial Name: NCT04211935 — N/A
MIRPE (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04211935 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum
2020. "Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04211935.
~3 spots leftby Jun 2024
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