Evidence map›Paper›PMID 38531584›Full record

ArticleBMJ open2024

Intercostal nerve cryoablation versus thoracic epidural analgesia for minimal invasive Nuss repair of pectus excavatum: a protocol for a randomised clinical trial (ICE trial).

Nicky Janssen, Jean H T Daemen, Aimée J P M Franssen, Elise J van Polen, Lori M van Roozendaal, Karel W E Hulsewé, Yvonne Vissers, Erik R de Loos

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05731973 (Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
2.3field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05731973 nacompletednot on this map

Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum: a Randomized Clinical Trial (ICE Trial)

TypeinterventionalSponsorZuyderland Medisch CentrumRan2023 to 2025Enrolled50ConditionsPectus Excavatum, Funnel ChestArmsIntercostal nerve cryoablation, Thoracic epidural analgesia (continuous infusion with sufentanyl (1 µg/ml) and bupivacaine (1.25 mg/ml)), Intercostal nerve block (single shot bupivacaine (1.25 mg/ml)), Opioids (oxycodone with prolonged discharge 10 mg PO every 12 hours and oxycodone 5 mg every 6 hours, as needed)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 4 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Nicky JanssenDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Jean H T DaemenDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Aimée J P M FranssenDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Elise J van PolenDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Lori M van RoozendaalDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Karel W E HulsewéDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Yvonne VissersDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Erik R de LoosDepartment of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands e.deloos@zuyderland.nl.ORCID 0000-0001-6313-2658
Zuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEpidural analgesia is currently considered the gold standard in postoperative pain management for the minimally invasive Nuss procedure for pectus excavatum. Alternative analgesic strategies (eg, patient-controlled analgesia and paravertebral nerve block) fail in accomplishing adequate prolonged pain management. Furthermore, the continuous use of opioids, often prescribed in addition to all pain management strategies, comes with side effects. Intercostal nerve cryoablation seems a promising novel technique. Hence, the primary objective of this study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared with standard pain management of young pectus excavatum patients treated with the minimally invasive Nuss procedure. METHODS AND ANALYSIS: This study protocol is designed for a single centre, prospective, unblinded, randomised clinical trial. Intercostal nerve cryoablation will be compared with thoracic epidural analgesia in 50 young pectus excavatum patients (ie, 12-24 years of age) treated with the minimally invasive Nuss procedure. Block randomisation, including stratification based on age (12-16 years and 17-24 years) and sex, with an allocation ratio of 1:1 will be performed.Postoperative length of hospital stay will be recorded as the primary outcome. 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. ETHICS AND DISSEMINATION: This protocol has been approved by the local Medical Ethics Review Committee, METC Zuyderland and Zuyd University of Applied Sciences. Participation in this study will be voluntary and informed consent will be obtained. Regardless of the outcome, the results will be disseminated through a peer-reviewed international medical journal. TRIAL REGISTRATION NUMBER: NCT05731973.

Indexed as

Analgesia, EpiduralCryosurgeryFunnel ChestAdolescentAnalgesics, OpioidChildHumansIntercostal NervesMinimally Invasive Surgical ProceduresPostoperative PainProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRetrospective StudiesAnalgesics, OpioidPaediatric thoracic surgeryPain managementRandomized Controlled TrialThoracic surgery

Identifiers

PMID38531584
PMCPMC10966815
OpenAlexW4393203188

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.