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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

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

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.

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

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 .

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