Machine Learning Prediction of Spinal Anaesthesia Block Duration

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSpecialized Medical Center (SMC)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults scheduled for elective surgery under single-shot spinal anaesthesia

ASA physical status I to III

Written informed consent obtained

Disqualifiers

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

Trial population

Consecutive adults scheduled for elective surgery under single-shot spinal anaesthesia at Specialized Medical Center, King Fahad campus, Riyadh.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Duration of sensory block

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

Time frame
Up to 8 hours after intrathecal injection
2

Duration of motor block

Time from completion of intrathecal injection to return to modified Bromage score 0 (full ability to flex knee and ankle)

Time frame
Up to 8 hours after intrathecal injection

Secondary outcomes

1

Predictive performance of machine learning models

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

Time frame
Through study completion, an average of 20 months
2

Time to peak sensory block level

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

Time frame
Up to 30 minutes after intrathecal injection

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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