Finding the best pain relief method after minimally invasive chest surgery for pectus excavatum
The Use of Video-assisted Intercostal Nerve Cryoablation, Erector Spinae Block, and Thoracic Epidural for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
This study is testing which pain relief method works best for people recovering from minimally invasive chest surgery for pectus excavatum.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04211935 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of three different postoperative pain management techniques—Patient-Controlled Analgesia (PCA), Epidural Analgesia (ESB), and Intravenous Narcotics (INC)—for patients undergoing minimally invasive repair of pectus excavatum (MIRPE). The study will involve a prospective randomized design, where participants will be assigned to one of the three pain control methods while following a multimodal enhanced recovery pathway. The goal is to determine which method provides the best pain relief while minimizing narcotic use and ensuring patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 13 to 18 years who are scheduled to undergo MIRPE for pectus excavatum.
Not a fit: Patients who are younger than 13 years, older than 18 years, or have a history of chronic narcotic use or previous thoracic surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing surgery for pectus excavatum, enhancing their recovery experience.
How similar studies have performed: While previous studies have shown comparable outcomes for ESB and INC, this trial is novel as it directly compares these techniques in a prospective manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with a pectus excavatum deformity that will undergo a MIRPE procedure will be included in the study. Exclusion Criteria: * \< 13 years old * \> 18 years old * chronic narcotic preoperative use * previous repair of pectus excavatum deformity * previous thoracic surgery * pregnancy
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Jose L Diaz-Miron, MD
- Email: jose.diaz-miron@childrenscolorado.org
- Phone: 720-777-6571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.