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 pectus excavatum patients treated with the minimal invasive Nuss…
ID
Source
Brief title
Condition
- Thoracic disorders (excl lung and pleura)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative length of hospital stay will be recorded as the primary endpoint.
Secondary outcome
Secondary outcomes include: 1) pain intensity 2) operative duration; 3) opioid
usage; 4) cryoanalgesia- or epidural-related complications including
neuropathic pain; 5) creatine kinase activity; 6) intensive care unit
admissions; 7) readmissions; 8) mobility; 9) health related quality of Life;
10) days to return to work/school; 11) number of postoperative outpatient
visits and 12) hospital costs.
Background summary
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).
Study 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 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 comparing intercostal nerve cryoablation with
thoracic epidural analgesia in pectus excavatum patients treated with the
minimal invasive Nuss procedure. Block randomization, including stratification
based on age and gender, with an allocation ratio of 1:1 will be performed.
Intervention
Intercostal nerve cryoablation complemented with intercostal nerve blocks.
Study burden and risks
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 (17-25). In case of neuropathic pain, the patient will be referred
to the pain specialist. Also, participants will be monitored daily by nursing
staff and surgeons while admitted to the hospital. Video recordings of the
surgical procedure made with the videoscope will be stored in the electronic
patient file of each patient. Possible side effects related to the intervention
will be fully investigated and reported for the entire study period.
Burden associated with participation in this study consists of the completion
of three questionnaires on 4 different timepoints. This will take 10 minutes
per timepoint. Furthermore, one extra venous blood sampling will be performed.
Possible benefit consists of more successful pain management and therefore
shorter length of postoperative hospital stay and better recovery.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
Pectus excavatum patients, 12-24 years, who undergo the Nuss procedure
Exclusion criteria
1. A chest wall deformity other than pectus excavatum;
2. Opioid use in the 3 months prior to surgery;
3. Pain syndrome (e.g., fibromyalgia) or neuropathic pain prior to surgical
repair of Pectus Excavatum;
4. Connective tissue disease (e.g., Marfan syndrome, Ehlers-Danlos syndrome);
5. Previous thoracic surgery or pectus excavatum repair;
6. Contraindication for INC or TEA (e.g., patient refusal, infection at the
site of cannulation, uncontrolled systemic infection, bleeding diathesis,
increased intracranial pressure, mechanical spine obstruction);
7. Psychiatric disease currently receiving treatment;
8. Not mastering the Dutch language;
9. Participation in another clinical trial that may interfere with the current
trial
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT:notyetassigned |
| CCMO | NL82316.096.23 |