Funnel Chest, Pectus Excavatum
Conditions
Keywords
Pectus Excavatum, Funnel Chest, Intercostal nerve cryoablation, Analgesia
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.
Detailed description
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.
Interventions
PROCEDUREIntercostal nerve cryoablation
Intercostal nerve cryoablation is applied during Nuss procedure.
DRUGThoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml))
Thoracic epidural is placed prior to Nuss procedure
DRUGIntercostal 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.
DRUGOpioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
Opioids
Sponsors
Zuyderland Medisch Centrum
AtriCure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Hospitalization period, average of 5 days | Number of days of hospital admittance after the Nuss procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pain intensity at rest and during mobilization. Pain scores will be rated on the numeric rating scale (NRS, 1-10) |
| Operative time | During Nuss procedure | 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. |
| Opioid usage | postoperative day 1 and 2, and first 2 weeks after surgery | 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). |
| Complications | 6 months postoperative | 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. |
| Creatine kinase (CK) activity | Preoperative and day 1 postoperative | 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. |
| Intensive care unit admission | Hospitalization period, average of 5 days | Intensive care unit admission due to the occurrence of perioperative complications in absolute numbers |
| Length of intensive care unit admission | Hospitalization period, average of 5 days | Length of admission due to the occurrence of perioperative complications in absolute numbers. |
| Number of readmissions | 6 months postoperative | Number of readmissions denoted as absolute numbers. |
| Length of readmissions | 6 months postoperative | length of readmissions denoted as absolute numbers. |
| Degree of mobility | Postoperative day 1 and 2 | 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. |
| HRQOL - PEEQ | Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure | 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). |
| HRQOL - SF-36 | Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure | 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). |
| HRQOL - EQ-5D-5L | Before surgery as a baseline measurement, and at 2 weeks, 3 months and 6 months after the surgical procedure | 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). |
| Days to return to work/school | 6 months postoperative | Days to return to work/school, reported as days between discharge from hospital and return to work or school. |
| Postoperative visits | 6 months postoperative | Number of postoperative outpatient visits and telephone appointments denoted as absolute numbers in the first 6 months after the surgical procedure. |
| Hospital costs | 6 months postoperative | 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). |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORErik R De Loos
Zuyderland Medical Center
Outcome results
None listed