- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07697053
Predictors of Epidural Depth in Percutaneous Nephrolithotomy and Model Development
Analysis of Factors Influencing Epidural Depth in Patients Undergoing Percutaneous Nephrolithotomy and Development of a Predictive Model
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical procedure for removal of kidney stones larger than 2 cm and is established as the gold standard for the management of complex renal calculi. This procedure may be performed under either general anesthesia or regional anesthesia, including epidural or spinal anesthesia. Accumulating meta-analyses have demonstrated that, compared with general anesthesia, regional anesthesia is associated with reduced postoperative pain scores and lower total hospital costs, without compromising the stone-free rate. Furthermore, in awake patients undergoing regional anesthesia, respiratory movements may generate a so-called "respiratory-synchronous stone fragmentation effect," which facilitates the expulsion of stone debris.
Successful epidural anesthesia relies critically on accurate identification of the epidural space and precise control of puncture depth. Insufficient puncture depth may result in improper catheter placement and subsequent block failure, whereas excessive puncture depth increases the risk of dural puncture, leading to cerebrospinal fluid leakage and post-dural puncture headache. In severe cases, inadvertent injection of a large dose of local anesthetics into the subarachnoid space can cause life-threatening cardiovascular and respiratory depression. Therefore, preprocedural estimation of the skin-to-epidural space distance is of considerable clinical importance.
Although racial differences in epidural depth have been reported, systematic investigations specifically targeting the Chinese population remain scarce. Various imaging modalities, including computed tomography, magnetic resonance imaging, and ultrasound, can be used to predict epidural depth. However, these examinations increase healthcare burden and are not always feasible in emergency or bedside settings. Consequently, identifying simple, easily obtainable clinical parameters-such as sex, age, and body mass index (BMI)-for predicting epidural depth has become a research priority.
In this context, the present study aimed to identify factors influencing epidural depth through a retrospective analysis of clinical data from PCNL patients and to develop simple, level-specific predictive models for different puncture sites, thereby providing a practical reference for clinical epidural anesthesia.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hongbo Zheng, MM
- Numéro de téléphone: +8618040544926
- E-mail: zheng1283@163.com
Sauvegarde des contacts de l'étude
- Nom: Hong Chen Chen, MM
- Numéro de téléphone: 17786127071
- E-mail: 2010tj0573@hust.edu.cn
Lieux d'étude
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Hubei
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Wuhan, Hubei, Chine, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Contact:
- Hongbo Zheng, MM
- Numéro de téléphone: +8618040544926
- E-mail: zheng1283@163.com
-
Contact:
- E-mail: zheng1283@163.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age ≥ 18 years
- Successful epidural puncture and catheter placement using the midline approach
- Clear documentation of puncture level and puncture depth in the anesthesia record
Exclusion Criteria:
- Dural puncture during anesthesia (including those who subsequently had a successful repuncture)
- Use of the paramedian approach for epidural puncture
- Uncertain epidural anesthesia effect requiring combined general anesthesia
- Incomplete clinical data
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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T11-T12
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the T11-T12 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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T12-L1
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the T12-L1 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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L1-L2
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the L1-L2 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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L2-L3
On operating room admission, after providing written informed consent for anesthesia, patients underwent standard monitoring (ECG, NIBP, pulse oximetry).
Baseline demographic and anthropometric data, including hospital admission ID, sex, height, and weight, were recorded, and body mass index (BMI) was calculated.
After positioning in the lateral decubitus position, the L2-L3 interspace was selected for puncture using a midline approach, and the loss-of-resistance technique confirmed epidural space entry.
Puncture depth (skin-to-epidural space) was recorded from needle shaft markings to the nearest 0.1 cm.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Epidural depth
Délai: Perioperative/Periprocedural
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Epidural depth, defined as the vertical distance from the skin surface to the epidural space measured at the time of puncture using the loss-of-resistance technique via the midline approach.
Depth was recorded from the needle shaft markings to the nearest 0.1 cm.
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Perioperative/Periprocedural
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adjusted R²
Délai: through study completion, an average of 1 month
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The coefficient of determination adjusted for the number of predictors in the model, reflecting the proportion of variance in epidural depth explained by the predictive model at each puncture level.
Higher values indicate better model fit.
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through study completion, an average of 1 month
|
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Root mean square error (RMSE)
Délai: through study completion, an average of 1 month
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The square root of the average squared difference between the model-predicted epidural depth and the actual measured depth, expressed in cm.
Lower values indicate better predictive accuracy of the model at each puncture level.
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through study completion, an average of 1 month
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hongbo Zheng, MM, Tongji Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- EDPN
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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