An interventional study of Intercostal nerve cryoablation and Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml)) in Pectus Excavatum and Funnel Chest, sponsored by Zuyderland Medisch Centrum. Completed at 1 site in Netherlands. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Other
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.
Rationale: The minimal invasive Nuss procedure is currently considered the treatment of choice for pectus excavatum. This procedure is usually associated with severe postoperative pain as great forces are employed on the thoracic cage to correct the sternal depression. Pain is the main limiting factor for early discharge. Epidural analgesia is currently considered gold standard for postoperative pain treatment. Alternative pain management strategies (e.g., patient-controlled analgesia and paravertebral nerve block) have also been described but fail in accomplishing adequate prolonged post-operative pain management. Alternatively, continuous use of opioids comes with side-effects like severe nausea, urinary retention and obstipation. Intercostal nerve cryoablation seems a promising novel technique for postoperative analgesia. Prior studies comparing intercostal cryoablation to other pain treatment modalities after pectus excavatum repair through the minimal invasive Nuss procedure report promising results, but pose significant limitations (e.g., small sample size, retrospective nature with non-matched patient groups or considerable confounders).
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Intercostal nerve cryoablation is applied during Nuss procedure.
Also known as: Cryoablation
Thoracic epidural is placed prior to Nuss procedure
Also known as: Epidural
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
Drug page: Opioids
Opioids
Also known as: opioids, oxycodone (with prolonged discharge)
Length of hospital stay
Number of days of hospital admittance after the Nuss procedure.
Time frame: Hospitalization period, average of 5 days
Pain intensity
Pain intensity at rest and during mobilization. Pain scores will be rated on the numeric rating scale (NRS, 1-10)
Time frame: 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
Operative time in minutes. Duration of cryoablation will be assessed separately. Operative time will not include the time needed for the placement of the thoracic epidural as placement will be performed in the preoperative care unit.
Time frame: During Nuss procedure
Opioid usage
A) Intraoperative administered opioids; B) Opioid usage during postoperative day 0, 1 and 2 at the recovery unit and surgical ward; C) Opioid usage within the first 2 weeks after surgery. Opioid usage will be converted to oral morphine milligram equivalents (MME).
Time frame: postoperative day 1 and 2, and first 2 weeks after surgery
Complications
Complications graded according to the Clavien-Dindo classification. The most common procedure- and analgesia-related complications are defined in Supplementary Materials Table 1-2 for transparency, including neuropathic pain. Occurrence of neuropathic pain will be actively monitored during the hospitalization period, and during all follow-up appointments.
Time frame: 6 months postoperative
Creatine kinase (CK) activity
CK levels will be assessed prior to the surgical procedure (i.e., baseline measurement during routine blood evaluation on the day of surgery) and on postoperative day 1. CK levels will be denoted in U/L.
Time frame: Preoperative and day 1 postoperative
Intensive care unit admission
Intensive care unit admission due to the occurrence of perioperative complications in absolute numbers
Time frame: Hospitalization period, average of 5 days
Length of intensive care unit admission
Length of admission due to the occurrence of perioperative complications in absolute numbers.
Time frame: Hospitalization period, average of 5 days
Number of readmissions
Number of readmissions denoted as absolute numbers.
Time frame: 6 months postoperative
Length of readmissions
length of readmissions denoted as absolute numbers.
Time frame: 6 months postoperative
Degree of mobility
Degree of mobility measured on a 4-point scale (i.e., 1. on the bed, 2. to the chair, 3. to the toilet, 4. outside the patient's hospital room) during postoperative day 1 and 2.
Time frame: Postoperative day 1 and 2
HRQOL - PEEQ
HRQOL, measured by the Dutch version of the pectus evaluation questionnaire (PEEQ). The PEEQ is a validated disease specific questionnaire evaluating the quality of life in pectus excavatum patients (37,38).
Time frame: Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL - SF-36
HRQOL, measured by the Dutch version of the short form health survey (SF-36)(37-40). The SF-36 is a generic questionnaire that taps health in eight dimensions (39).
Time frame: Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
HRQOL - EQ-5D-5L
HRQOL, measured by the Dutch version of the EuroQol 5 dimensions 5 levels (EQ-5D-5L) (37-40). For the EQ-5D-5L, participants will rate their health in 5 dimensions on 5 levels and will give an overall score of their health on a visual analogue scale (VAS) (40).
Time frame: Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure
Days to return to work/school
Days to return to work/school, reported as days between discharge from hospital and return to work or school.
Time frame: 6 months postoperative
Postoperative visits
Number of postoperative outpatient visits and telephone appointments denoted as absolute numbers in the first 6 months after the surgical procedure.
Time frame: 6 months postoperative
Hospital costs
Hospital costs, reported as hospital costs during initial hospitalization (e.g., medication, patient care supply, surgical equipment), and hospital costs after discharge until 6 months follow-up (e.g., medications, outpatient visits, (opioid related) readmissions).
Time frame: 6 months postoperative
Plan to share: No
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Zuyderland Medisch Centrum