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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage pain after the Nuss procedure, which corrects a sunken chest (pectus excavatum). Participants will receive either an ES catheter (a type of epidural catheter) or intercostal nerve cryoablation (INC, a procedure that uses cold to numb nerves) to alleviate post-surgery pain. The trial aims to determine which method aids faster recovery of physical abilities, reduces opioid use, and affects sensation and pain. Ideal participants are aged 12-21, have a history of sunken chest, and are scheduled for a Nuss procedure. As an unphased trial, this study allows participants to contribute to innovative pain management strategies for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both ES catheters and intercostal nerve cryoablation (INC) are generally safe for managing pain after chest surgeries like the Nuss procedure. ES catheters effectively control pain, but significant pain may persist after removal, necessitating additional pain relief.

Studies on intercostal nerve cryoablation indicate it is a safe option for pain relief. It effectively controls pain and reduces the need for opioids. INC works by temporarily freezing the nerves, easing pain without causing permanent nerve damage.

Both treatments have been successfully used in surgeries and offer different methods for pain management. Each has its strengths, and both are considered well-tolerated options for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for sunken chest surgery because they offer innovative ways to manage postoperative pain. The ES catheter is unique as it provides targeted pain relief directly at the surgery site, potentially reducing the need for systemic pain medications like opioids. On the other hand, intercostal nerve cryoablation (INC) uses extreme cold to temporarily block nerve pain signals, which could offer longer-lasting pain relief compared to traditional nerve blocks. Both techniques aim to minimize discomfort and speed up recovery, promising a more comfortable postoperative experience for patients.

What evidence suggests that this trial's treatments could be effective for pain management after the Nuss procedure?

This trial will compare the effectiveness of ES catheters and intercostal nerve cryoablation (INC) for managing pain after the Nuss procedure. Research has shown that both treatments hold promise for postoperative pain management. Participants in the ES catheter group may need fewer opioids and have shorter hospital stays. Meanwhile, those in the INC group, which involves freezing nerves to numb them, may also experience improved pain control and reduced opioid use. Both treatments aim to help patients recover more comfortably and quickly by effectively managing pain. Overall, these methods have the potential to enhance recovery by minimizing pain and reducing the need for strong painkillers. ^{2 3 5 6 7}

Who Is on the Research Team?

Surya Narayanasamy, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Charlotte Walter, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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 have a chronic pain condition such as Ehlers Danlos Syndrome.

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

I am undergoing other surgeries alongside my cancer treatment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 (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]

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]

Citations

1. jtd.amegroups.org jtd.amegroups.org/article/view/8554/html

Randomized trial of epidural vs. subcutaneous catheters for ... This prospective, randomized trial was performed to determine if bilateral subcutaneous local anesthetic catheters would provide adequate analgesia with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35907711/

Retrospective study comparing outcomes of multimodal ... Compared to EPI, multimodal ambulatory ESP protocol decreased LOS and postoperative opioid use, with comparable ED visits/readmissions.

3. researchgate.net researchgate.net/publication/260643560_A_comparison_of_paravertebral_nerve_block_catheters_and_thoracic_epidural_catheters_for_postoperative_analgesia_following_the_Nuss_procedure_for_pectus_excavatum_repair

A comparison of paravertebral nerve block catheters and ... A comparison of paravertebral nerve block catheters and thoracic epidural catheters for postoperative analgesia following the Nuss procedure for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9717353/

Pain management for the Nuss procedure - PubMed Central ESP resulted in reduced opioid consumption postoperatively and shorter LOS than TE or PCA for patients undergoing the Nuss procedure for ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/prm/8823617

Best Evidence Summary for Perioperative Pain ... However, even with epidural analgesia, severe pain can persist postremoval of the catheter, highlighting the need for additional pain management ...

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Safety and efficacy of high thoracic epidural analgesia for ... Safety and efficacy of high thoracic epidural analgesia for chest wall surgery in young adolescents: A retrospective cohort analysis and a new ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00394459

Safety of Two Epidural Catheters in Thoracic ... Based on this, it is expected that paraesthesias during catheter injection can be reduced by at least 20%. Official Title. Randomised, Prospective, Single-blind ...