Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum

NCT05731973 | Completed

• 1 other identifier: Z2023005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of the current study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared to standard pain management of young pectus excavatum patients (12-24 years) treated with the minimal invasive Nuss procedure. The study is designed as a single center, prospective, unblinded, randomized clinical trial.

Conditions

Pectus Excavatum; Funnel Chest

Keywords

Pectus Excavatum; Funnel Chest; Intercostal nerve cryoablation; Analgesia

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Number of days of hospital admittance after the Nuss procedure.

  Hospitalization period, average of 5 days

Secondary Outcomes (16)

• Pain intensity

  Preoperative care unit before surgery, in the morning on postoperative day 1 and 2, and 7 days, 14 days, 3 months and 6 months post operation

• Operative time

  During Nuss procedure

• Opioid usage

  postoperative day 1 and 2, and first 2 weeks after surgery

• Complications

  6 months postoperative

• Creatine kinase (CK) activity

  Preoperative and day 1 postoperative

Study Arms (2)

Intercostal nerve cryoablation

EXPERIMENTAL

When a patient is allocated to the intercostal nerve cryoablation group, cryoablation will be performed prior to bar placement. In brief, cryoablation will be performed at the level of the bar and two levels above and below, bilaterally. For this, a second portal access will be placed for video guidance on the contralateral side, and the cryoprobe (cryoICE, Atricure, Masion, OH, USA) will be inserted through the thoracic incisions that are already made for bar placement. The probe will be placed at the inferior aspect of the ribs, posterior to the midaxillary line, directly on the neurovascular bundle. One freezing cycle takes 2 minutes, and a temperature of -60 ⁰C will be applied. The probe will be warmed to room temperature before removing it from the pleura to prevent additional trauma. Furthermore, intercostal nerve cryoablation will be combined with single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks placed just anterior to the side of the cryoablation.

Procedure: Intercostal nerve cryoablation; Drug: Intercostal nerve block (single shot bupivacaine (1.25 mg/ml)); Drug: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)

Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))

ACTIVE COMPARATOR

Prior to surgery, an anesthesiologist will place the thoracic epidural at T5-T6 or T6-T7 interspace in the awake patient. After correct placement, a local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml) will be started. At the third postoperative day, thoracic epidural analgesia will be ceased and transitioned to oral pain medication at discretion of the pain management team. In general, opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours as needed) will be provided 12 hours before thoracic epidural analgesia is ceased.

Drug: Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml)); Drug: Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)

Interventions

Intercostal nerve cryoablation PROCEDURE

Intercostal nerve cryoablation is applied during Nuss procedure.

Also known as: Cryoablation

Intercostal nerve cryoablation

Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml)) DRUG

Thoracic epidural is placed prior to Nuss procedure

Also known as: Epidural

Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))

Intercostal nerve block (single shot bupivacaine (1.25 mg/ml)) DRUG

Single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks are placed just anterior to the side of the cryoablation.

Also known as: Intercostal nerve block

Intercostal nerve cryoablation

Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed) DRUG

Opioids

Also known as: opioids, oxycodone (with prolonged discharge)

Intercostal nerve cryoablation; Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing the minimal invasive Nuss procedure for surgical repair of pectus excavatum.
• Young patients (12-24 years of age) according to the definition used by the World Health Organization. This cut-off point is chosen to create a more homogenous patient sample, as the thoracic cage is fully matured by the age of 24, in size and density, which will have an effect on postoperative pain.

You may not qualify if:

• A chest wall deformity other than pectus excavatum;
• Opioid use in the 3 months prior to surgery;
• Pain syndrome (e.g., fibromyalgia) or neuropathic pain prior to surgical repair of pectus excavatum;
• Connective tissue disease (e.g., Marfan syndrome, Ehlers-Danlos syndrome);
• Previous thoracic surgery or pectus excavatum repair;
• Contraindication for intercostal nerve cryoablation or thoracic epidural analgesia (e.g., patient refusal, infection at the site of cannulation, uncontrolled systemic infection, bleeding diathesis, increased intracranial pressure, mechanical spine obstruction);
• Psychiatric disease currently receiving treatment;
• Not mastering the Dutch language;
• Participation in another clinical trial that may interfere with the current trial.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• AtriCure, Inc.: collaborator

Study Sites (1)

Zuyderland Medical Center

Heerlen, Limburg, 6419 PC, Netherlands

Location

Related Publications (17)

• Croitoru DP, Kelly RE Jr, Goretsky MJ, Lawson ML, Swoveland B, Nuss D. Experience and modification update for the minimally invasive Nuss technique for pectus excavatum repair in 303 patients. J Pediatr Surg. 2002 Mar;37(3):437-45. doi: 10.1053/jpsu.2002.30851.

  PMID: 11877663 RESULT

• Nuss D. Minimally invasive surgical repair of pectus excavatum. Semin Pediatr Surg. 2008 Aug;17(3):209-17. doi: 10.1053/j.sempedsurg.2008.03.003.

  PMID: 18582827 RESULT

• Nuss D, Kelly RE Jr. Indications and technique of Nuss procedure for pectus excavatum. Thorac Surg Clin. 2010 Nov;20(4):583-97. doi: 10.1016/j.thorsurg.2010.07.002.

  PMID: 20974443 RESULT

• Dekonenko C, Dorman RM, Duran Y, Juang D, Aguayo P, Fraser JD, Oyetunji TA, Snyder CL, Holcomb GW 3rd, Millspaugh DL, St Peter SD. Postoperative pain control modalities for pectus excavatum repair: A prospective observational study of cryoablation compared to results of a randomized trial of epidural vs patient-controlled analgesia. J Pediatr Surg. 2020 Aug;55(8):1444-1447. doi: 10.1016/j.jpedsurg.2019.09.021. Epub 2019 Oct 26.

  PMID: 31699436 RESULT

• Qi J, Du B, Gurnaney H, Lu P, Zuo Y. A prospective randomized observer-blinded study to assess postoperative analgesia provided by an ultrasound-guided bilateral thoracic paravertebral block for children undergoing the Nuss procedure. Reg Anesth Pain Med. 2014 May-Jun;39(3):208-13. doi: 10.1097/AAP.0000000000000071.

  PMID: 24682079 RESULT

• Sertcakacilar G, Kose S. Bilateral PECS II Block is Associated with Decreased Opioid Consumption and Reduced Pain Scores for up to 24 hours After Minimally Invasive Repair of Pectus Excavatum (Nuss Procedure): A Retrospective Analysis. J Cardiothorac Vasc Anesth. 2022 Oct;36(10):3833-3840. doi: 10.1053/j.jvca.2022.06.001. Epub 2022 Jun 6.

  PMID: 35817669 RESULT

• Abdel Shaheed C, McLachlan AJ, Maher CG. Rethinking "long term" opioid therapy. BMJ. 2019 Nov 29;367:l6691. doi: 10.1136/bmj.l6691. No abstract available.

  PMID: 31784472 RESULT

• Cadaval Gallardo C, Martinez J, Bellia-Munzon G, Nazar M, Sanjurjo D, Toselli L, Martinez-Ferro M. Thoracoscopic cryoanalgesia: A new strategy for postoperative pain control in minimally invasive pectus excavatum repair. Cir Pediatr. 2020 Jan 20;33(1):11-15. English, Spanish.

  PMID: 32166917 RESULT

• Aiken TJ, Stahl CC, Lemaster D, Casias TW, Walker BJ, Nichol PF, Leys CM, Abbott DE, Brinkman AS. Intercostal nerve cryoablation is associated with lower hospital cost during minimally invasive Nuss procedure for pectus excavatum. J Pediatr Surg. 2021 Oct;56(10):1841-1845. doi: 10.1016/j.jpedsurg.2020.10.009. Epub 2020 Oct 19.

  PMID: 33199059 RESULT

• Morikawa N, Laferriere N, Koo S, Johnson S, Woo R, Puapong D. Cryoanalgesia in Patients Undergoing Nuss Repair of Pectus Excavatum: Technique Modification and Early Results. J Laparoendosc Adv Surg Tech A. 2018 Sep;28(9):1148-1151. doi: 10.1089/lap.2017.0665. Epub 2018 Apr 19.

  PMID: 29672193 RESULT

• Harbaugh CM, Johnson KN, Kein CE, Jarboe MD, Hirschl RB, Geiger JD, Gadepalli SK. Comparing outcomes with thoracic epidural and intercostal nerve cryoablation after Nuss procedure. J Surg Res. 2018 Nov;231:217-223. doi: 10.1016/j.jss.2018.05.048. Epub 2018 Jun 21.

  PMID: 30278932 RESULT

• Sun RC, Mehl SC, Anbarasu CR, Portuondo JI, Espinoza AF, Whitlock R, Mazziotti MV. Intercostal cryoablation during Nuss procedure: A large volume single surgeon's experience and outcomes. J Pediatr Surg. 2021 Dec;56(12):2229-2234. doi: 10.1016/j.jpedsurg.2021.03.006. Epub 2021 Mar 17.

  PMID: 33853732 RESULT

• Sujka J, Benedict LA, Fraser JD, Aguayo P, Millspaugh DL, St Peter SD. Outcomes Using Cryoablation for Postoperative Pain Control in Children Following Minimally Invasive Pectus Excavatum Repair. J Laparoendosc Adv Surg Tech A. 2018 Nov;28(11):1383-1386. doi: 10.1089/lap.2018.0111. Epub 2018 Jun 21.

  PMID: 29927703 RESULT

• Daemen JHT, de Loos ER, Vissers YLJ, Bakens MJAM, Maessen JG, Hulsewe KWE. Intercostal nerve cryoablation versus thoracic epidural for postoperative analgesia following pectus excavatum repair: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2020 Oct 1;31(4):486-498. doi: 10.1093/icvts/ivaa151.

  PMID: 32929487 RESULT

• Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.

  PMID: 30935731 RESULT

• Zobel MJ, Ewbank C, Mora R, Idowu O, Kim S, Padilla BE. The incidence of neuropathic pain after intercostal cryoablation during the Nuss procedure. Pediatr Surg Int. 2020 Mar;36(3):317-324. doi: 10.1007/s00383-019-04602-1. Epub 2019 Nov 23.

  PMID: 31760443 RESULT

• Janssen N, Daemen JHT, Franssen AJPM, van Polen EJ, van Roozendaal LM, Hulsewe KWE, Vissers Y, de Loos ER. Intercostal nerve cryoablation versus thoracic epidural analgesia for minimal invasive Nuss repair of pectus excavatum: a protocol for a randomised clinical trial (ICE trial). BMJ Open. 2024 Mar 25;14(3):e081392. doi: 10.1136/bmjopen-2023-081392.

  PMID: 38531584 DERIVED

Related Links

• FDA

MeSH Terms

Conditions

Funnel Chest; Agnosia

Interventions

Cryosurgery; Tea; Sufentanil; Bupivacaine; Injections, Epidural; Analgesics, Opioid; Oxycodone; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Erik R De Loos

  Zuyderland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single center, prospective, unblinded, randomized clinical trial. Block randomization, including stratification based on age (12-16 years and 17-24 years) and sex, with an allocation ratio of 1:1 will be performed.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 16, 2023
• Study Start: December 8, 2023
• Primary Completion: April 5, 2025
• Study Completion: October 22, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)