ES Catheter vs Cryoablation for Sunken Chest Surgery

Overseen By Kristie Geisler, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Opioids

Disqualifiers: Chronic pain, Non-English, Severe delays, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days

176 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups: * Time to achieve short-term physical therapy goals and long-term functional outcomes * Compare immediate and long-term postoperative opioid use * Compare numbness on chest of postoperative day 1 and the return of sensation to baseline * Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.

Do I need to stop my current medications for this 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 coordinators or your doctor.

What data supports the effectiveness of the treatment ES Catheter vs Cryoablation for Sunken Chest Surgery?

Research shows that intercostal nerve cryoablation (INC) can reduce the need for opioids (strong painkillers) and shorten hospital stays in patients undergoing chest surgeries, like pectus excavatum repair and rib fracture stabilization. This suggests that INC may help manage pain effectively in sunken chest surgery. ^{1 2 3 4 5}

Is intercostal nerve cryoablation safe for humans?

Intercostal nerve cryoablation (INC) has been used in various surgeries, such as rib fracture stabilization and pectus excavatum repair, and is generally considered safe without immediate or long-term complications. However, it may lower body temperature and increase the risk of infections, especially in children undergoing certain procedures. ^{1 2 3 6 7}

How does the ES Catheter vs Cryoablation treatment for sunken chest surgery differ from other treatments?

The ES Catheter vs Cryoablation treatment for sunken chest surgery is unique because it uses intercostal nerve cryoablation (INC), which has been shown to reduce pain and opioid use, leading to shorter hospital stays compared to traditional methods like thoracic epidural. This approach is particularly beneficial in managing post-operative pain effectively. ^{1 2 3 5 8}

Research Team

Charlotte Walter, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Surya Narayanasamy, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for individuals who have undergone the Nuss procedure to correct a sunken chest condition known as Pectus Excavatum. Participants should be able to complete surveys for up to a year after surgery.

Inclusion Criteria

History of pectus excavatum

I am scheduled for a chest wall correction surgery.

I am between 12 and 21 years old.

Exclusion Criteria

I do not have severe breathing issues like sleep apnea or lung fibrosis.

I am undergoing other surgeries alongside my cancer treatment.

I have had surgery to correct pectus (chest wall) deformity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ES catheter or intercostal nerve cryoablation for pain management after the Nuss procedure

Up to 10 days

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness, including surveys and assessments of opioid use, numbness, and neuropathic pain

12 months

Surveys and assessments at multiple intervals

Treatment Details

Interventions

• ES catheter
• Intercostal nerve cryoablation (INC)

Trial Overview The study compares two pain management techniques post-surgery: an ES catheter and intercostal nerve cryoablation (INC). It will assess how quickly patients meet physical therapy goals, their opioid use, sensation recovery on the chest, and any neuropathic pain or complications.

Participant Groups

Group I: ES Catheter Active Control 1 Intervention

Hospital procedure for ES catheters will be followed for postoperative pain.

Group II: Intercostal Nerve Cryoablation (INC) Active Control 1 Intervention

Hospital procedure for intercostal nerve cryoablation will be followed for postoperative pain.

ES catheter is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidural catheter for:

• Pain management after pectus excavatum surgery

Approved in European Union as Paravertebral catheter for:

• Pain management after thoracic surgery
• Pain management after pectus excavatum surgery

Approved in Canada as Thoracic epidural catheter for:

• Pain management after thoracic surgery
• Pain management after pectus excavatum surgery

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Findings from Research

Intercostal nerve cryoablation (INC) significantly reduced hospital length of stay (LOS) to 2.5 days compared to 5 days for traditional thoracic epidural (TE) anesthesia in patients undergoing pectus excavatum repair, based on a study of 79 patients.

Patients receiving INC had lower total opioid use during their hospital stay and reduced long-term opioid use after discharge, indicating better pain management and potential for decreased opioid dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation is associated with shorter length of stay and reduced opioid use in pectus excavatum repair. Rettig, RL., Rudikoff, AG., Lo, HYA., et al.[2021]

Intercostal nerve cryoablation (INC) significantly reduces opioid use in children undergoing thoracotomy for cancer, with patients receiving INC using an average of 137.6 mg of oral morphine equivalents compared to 514.5 mg in those receiving routine care.

The study, which reviewed 26 patients over a 5-year period, found that while INC patients had lower opioid prescriptions upon discharge (30.4% vs. 80.0%), their length of hospital stay and rates of reoperation or readmission were similar to those receiving standard care, indicating that INC is a safe and effective adjunct for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation reduces opioid utilization after thoracotomy in children with cancer. McElhinney, KL., Zeineddin, S., Ahle, SL., et al.[2023]

In a study of 241 patients undergoing surgical stabilization of rib fractures, those who received intercostal nerve cryoablation used significantly fewer opioids post-operatively and had shorter stays in the intensive care unit compared to those who did not receive cryoablation.

Cryoablation did not increase the time spent in surgery or the risk of pulmonary complications, making it a safe adjunctive treatment that enhances pain management without additional risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. Marturano, MN., Thakkar, V., Wang, H., et al.[2023]

Image-guided percutaneous intercostal nerve cryoablation, using cone-beam computed tomography and software-assisted planning, is a feasible method for treating chronic post-thoracotomy pain syndrome (PTPS).

In a case study, this technique provided approximately 8 weeks of significant pain relief for a patient suffering from intractable PTPS, suggesting it may be a valuable option for managing this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided nerve cryoablation for post-thoracotomy pain syndrome. Koethe, Y., Mannes, AJ., Wood, BJ.[2021]

Intercostal nerve cryoablation (INC) significantly reduced hospital length of stay (LOS) to 2.8 days compared to 6 days for traditional thoracic epidural (TE) in patients undergoing the modified Ravitch procedure, based on a study of 37 patients.

Patients in the INC group also experienced lower total opioid use during hospitalization and reduced long-term opioid use after discharge, indicating effective pain management and potential for cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation is associated with shorter length-of-stay and reduced opioid use after the Ravitch procedure. Rettig, RL., Yang, CJ., Ashfaq, A., et al.[2022]

In a study of 80 patients undergoing minimally invasive repair of pectus excavatum (MIRPE), cryoanalgesia did not lead to a higher risk of postoperative infections or longer hospital stays compared to traditional pain management methods.

Despite cryoanalgesia causing a lower core body temperature during recovery, it was not associated with any significant differences in wound infections or pneumonia rates, suggesting it is a safe option for pain control in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious complications of intercostal nerve cryoablation mediated by perioperative hypothermia during pediatric Nuss procedure. Bundrant, NT., Sayrs, LW., Ostlie, D., et al.[2022]

Intercostal nerve cryoablation (IC) during surgical stabilization of rib fractures (SSRF) was found to be safe and feasible, with no significant immediate or long-term complications reported among the 20 patients who underwent the procedure.

While the study did not show a significant reduction in pain scores or opioid use for the SSRF-IC group compared to the SSRF group, further research is needed to fully evaluate the analgesic efficacy of IC for rib fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures. Choi, J., Min, JG., Jopling, JK., et al.[2023]

Patients undergoing the Nuss repair of pectus excavatum with intercostal nerve blocks (INB) had a significantly shorter hospital stay (average 11.8 hours) compared to those receiving only intercostal nerve cryoablation (INC) (average 58.2 hours), indicating improved pain management and recovery.

The majority of patients in the INB group were discharged on the same day of surgery (10 out of 15), while none in the INC group were able to do so, highlighting the efficacy of the INB approach in facilitating quicker recovery and reducing the need for postoperative pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day discharge following the Nuss repair: A comparison. Rettig, RL., Rudikoff, AG., Annie Lo, HY., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Cryoablation is associated with shorter length of stay and reduced opioid use in pectus excavatum repair. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation reduces opioid utilization after thoracotomy in children with cancer. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Image-guided nerve cryoablation for post-thoracotomy pain syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cryoablation is associated with shorter length-of-stay and reduced opioid use after the Ravitch procedure. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Infectious complications of intercostal nerve cryoablation mediated by perioperative hypothermia during pediatric Nuss procedure. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Same-day discharge following the Nuss repair: A comparison. [2022]