- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07816003
Machine Learning Prediction of Spinal Anaesthesia Block Duration
13 septembre 2026 mis à jour par: SalahEldin Ahmed Abdelaziz Ahmed, Specialized Medical Center (SMC)
Artificial Intelligence-Based Prediction of Sensory and Motor Block Duration Following Spinal Anaesthesia: A Prospective Observational Prediction Model Development Study
The duration of sensory and motor block after spinal anaesthesia varies widely between patients given the same dose of local anaesthetic.
Much of this variability is explained by differences in lumbosacral cerebrospinal fluid volume, which cannot be measured routinely in clinical practice but is related to simple body measurements such as abdominal circumference and vertebral column length.
This prospective observational study will develop and internally validate prediction models for the duration of sensory and motor block following spinal anaesthesia in adults undergoing elective surgery.
Preoperative clinical and anthropometric variables will be recorded, and block regression will be assessed serially after intrathecal injection.
Machine learning methods (lasso regression, ridge regression, random forest, extreme gradient boosting, and support vector regression) will be developed and compared against multivariable linear regression as the reference model.
The aim is a practical tool that helps anaesthetists anticipate how long a spinal block will last in an individual patient, supporting decisions about case scheduling, supplementation, and discharge planning.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
Background.
Spinal anaesthesia produces block of unpredictable duration.
Cerebrospinal fluid volume in the lumbosacral region is the dominant determinant of block spread and regression, and correlates inversely with abdominal circumference and directly with vertebral column length.
Existing single-variable rules perform poorly, and no validated multivariable model is in routine clinical use.
Objectives.
The primary objective is to develop and internally validate models predicting the duration of sensory block and the duration of motor block after single-shot spinal anaesthesia.
The secondary objective is to compare the predictive performance of machine learning approaches with conventional multivariable linear regression.
Design.
Single-centre prospective observational cohort study.
No study-directed intervention is applied; anaesthetic technique, drug, and dose are determined by the attending anaesthetist according to routine practice and are recorded as candidate predictors.
Assessments.
Sensory block level is assessed bilaterally by pinprick with a 25-gauge needle along the mid-clavicular line, over dermatomes T4 to S1. Motor block is assessed using the modified Bromage scale (0-3).
Assessments are performed at fixed intervals from intrathecal injection until complete regression of sensory and motor block.
Candidate predictors.
Age, sex, height, weight, body mass index, abdominal circumference, vertebral column length, ASA physical status, local anaesthetic dose and baricity, and adjuvant use.
Sample size.
A target of 255 participants was derived using the Riley criteria for continuous-outcome prediction models (pmsampsize), assuming 9 candidate predictors, an outcome standard deviation of 40 minutes, anticipated R-squared of 0.35, shrinkage of at least 0.90, and a multiplicative margin of error of 1.10.
The four criteria yielded 183, 183, 234, and 246; the largest requirement of 246 was inflated by approximately 4 per cent for attrition.
Analysis.
Model development will use nested repeated 10-fold cross-validation with bootstrap optimism correction.
Performance will be reported as R-squared, root mean squared error, and mean absolute error, with calibration plots.
SHAP values will be used to describe predictor contributions.
Reporting will follow TRIPOD+AI.
Type d'étude
Observationnel
Inscription (Estimé)
255
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Salaheldin A Abdelaziz Ahmed
- Numéro de téléphone: +966508818713
- E-mail: saladin28.sa@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Consecutive adults scheduled for elective surgery under single-shot spinal anaesthesia at Specialized Medical Center, King Fahad campus, Riyadh.
La description
Inclusion Criteria:
- Adults scheduled for elective surgery under single-shot spinal anaesthesia
- ASA physical status I to III
- Written informed consent obtained
Exclusion Criteria:
- Contraindication to neuraxial anaesthesia (coagulopathy, local or systemic infection, raised intracranial pressure, patient refusal)
- Failed or incomplete block requiring conversion to general anaesthesia
- Repeated or top-up intrathecal injection
- Pregnancy
- Known spinal deformity or previous spine surgery
- Pre-existing neurological or neuromuscular disease affecting sensory or motor assessment
- Inability to cooperate with sensory and motor assessment
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Duration of sensory block
Délai: Up to 8 hours after intrathecal injection
|
Time from completion of intrathecal injection to regression of sensory block to the S1 dermatome, assessed bilaterally by pinprick with a 25-gauge needle along the mid-clavicular line
|
Up to 8 hours after intrathecal injection
|
|
Duration of motor block
Délai: Up to 8 hours after intrathecal injection
|
Time from completion of intrathecal injection to return to modified Bromage score 0 (full ability to flex knee and ankle)
|
Up to 8 hours after intrathecal injection
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Predictive performance of machine learning models
Délai: Through study completion, an average of 20 months
|
R-squared, root mean squared error, mean absolute error, and calibration slope for lasso regression, ridge regression, random forest, extreme gradient boosting, and support vector regression, each compared with multivariable linear regression as the reference model
|
Through study completion, an average of 20 months
|
|
Time to peak sensory block level
Délai: Up to 30 minutes after intrathecal injection
|
Time from intrathecal injection to the highest dermatomal level of sensory block, assessed by pinprick
|
Up to 30 minutes after intrathecal injection
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Salaheldin A abdelaziz Ahmed, Specialized Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
1 juillet 2028
Achèvement de l'étude (Estimé)
1 septembre 2028
Dates d'inscription aux études
Première soumission
7 septembre 2026
Première soumission répondant aux critères de contrôle qualité
7 septembre 2026
Première publication (Réel)
11 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRBSMC1-2026-0001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data underlying published results, together with the data dictionary and model code, will be made available to researchers whose proposed use has been approved by an independent review committee.
Requests should be directed to the principal investigator.
Data will be available from 6 months to 36 months after publication of the primary results.
Délai de partage IPD
Data will become available 6 months after publication of the primary results and will remain available for 36 months
Critères d'accès au partage IPD
Requests should be directed to the principal investigator.
Proposals will be reviewed by the principal investigator and the Specialized Medical Center Institutional Review Board.
Requesters must provide a methodologically sound proposal and sign a data access agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .