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NCT Number: NCT07816003

Machine Learning Prediction of Spinal Anaesthesia Block Duration

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Duration of sensory block

    Time frame: 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

  2. Duration of motor block

    Time frame: 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)

Secondary outcomes

  1. Predictive performance of machine learning models

    Time frame: 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

  2. Time to peak sensory block level

    Time frame: Up to 30 minutes after intrathecal injection

    Time from intrathecal injection to the highest dermatomal level of sensory block, assessed by pinprick

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Specialized Medical Center (SMC)

Other

Registry information

Official study title

Artificial Intelligence-Based Prediction of Sensory and Motor Block Duration Following Spinal Anaesthesia: A Prospective Observational Prediction Model Development Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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