Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum
NCT ID: NCT05731973
Last Updated: 2024-01-05
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-12-08
2025-09-30
Brief Summary
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Detailed Description
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Objective: 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 treated with the minimal invasive Nuss procedure.
Study design: The study protocol is designed for a single center, prospective, unblinded, randomized clinical trial.
Study population \& intervention: Intercostal nerve cryoablation will be compared to thoracic epidural analgesia in young pectus excavatum patients (i.e., 12-24 years of age) treated with the minimal invasive Nuss procedure. 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.
Main study parameters/endpoints: Postoperative length of hospital stay will be recorded as the primary endpoint. Secondary outcomes include: 1) pain intensity; 2) operative time; 3) opioid usage; 4) complications, including neuropathic pain; 5) creatine kinase activity; 6)intensive care unit admissions; 7) readmissions; 8) postoperative mobility; 9) health related quality of Life; 10) days to return to work/school; 11) number of postoperative outpatient visits and 12) hospital costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for study participants are negligible as the cryoablation technique has already been effectively used in the Nuss procedure without any serious side effects. Also, participants will be monitored daily by nursing staff and surgeons while admitted to the hospital. Burden associated with participation in the current study consists of completion of several questionnaires preoperatively and postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intercostal nerve cryoablation
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.
Intercostal nerve cryoablation
Intercostal nerve cryoablation is applied during Nuss procedure.
Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))
Single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks are placed just anterior to the side of the cryoablation.
Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Thoracic epidural (local continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
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.
Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Thoracic epidural is placed prior to Nuss procedure
Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Interventions
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Intercostal nerve cryoablation
Intercostal nerve cryoablation is applied during Nuss procedure.
Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Thoracic epidural is placed prior to Nuss procedure
Intercostal nerve block (single shot bupivacaine (1.25 mg/ml))
Single shot bupivacaine (1.25 mg/ml) intercostal nerve blocks are placed just anterior to the side of the cryoablation.
Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
24 Years
ALL
No
Sponsors
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AtriCure, Inc.
INDUSTRY
Zuyderland Medisch Centrum
OTHER
Responsible Party
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Erik de Loos
Principal investigator
Principal Investigators
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Erik R De Loos
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medical Center
Locations
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Zuyderland Medical Center
Heerlen, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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Z2023005
Identifier Type: -
Identifier Source: org_study_id
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