Skip to content

Machine Learning Prediction of Spinal Anaesthesia Block Duration

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07816003
Enrollment
255
Registered
2026-09-11
Start date
2026-12-01
Completion date
2028-09-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Recovery Period, Anesthesia, Spinal, Nerve Block

Keywords

spinal anaesthesia, sensory block duration, motor block duration, abdominal circumference, vertebral column length, machine learning, prediction model, TRIPOD+AI

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Specialized Medical Center (SMC)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of sensory blockUp to 8 hours after intrathecal injectionTime 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
Duration of motor blockUp to 8 hours after intrathecal injectionTime from completion of intrathecal injection to return to modified Bromage score 0 (full ability to flex knee and ankle)

Secondary

MeasureTime frameDescription
Predictive performance of machine learning modelsThrough study completion, an average of 20 monthsR-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 to peak sensory block levelUp to 30 minutes after intrathecal injectionTime from intrathecal injection to the highest dermatomal level of sensory block, assessed by pinprick

Contacts

CONTACTSalaheldin A Abdelaziz Ahmed
saladin28.sa@gmail.com+966508818713
PRINCIPAL_INVESTIGATORSalaheldin A abdelaziz Ahmed

Specialized Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026