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Clinical Trials/CTRI/2026/01/102625
CTRI/2026/01/102625Not yet recruitingNot Applicable

Correlation of subarachnoid space depth obtained from formula versus actual measurement at lumbar region to derive appropriate formula in patients undergoing spinal anaesthesia at a tertiary care centre- An observational study

Bangalore medical college and research institute1 site in 1 country300 target enrollmentStarted: February 12, 2026Last updated:
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
1. correlation between subarachanoid space depth estimation by derived formula and the actual measurement at lumbar region in patients (males, females and pregnant women) undergoing spinal anesthesia."

Study Overview

Brief Summary

Subarachnoid block is a commonly practiced anaesthesia technique for lower abdominal and limb surgeries, including cesarean sections.Performed using an anatomical landmark guided, blind approach, its sucess depends on factors like height weight BMI and BSA.In conditions such as obesity, pregnancy or edema  estimating subaracnoid space depth is crucial to minimize failed attempts and complications. Existing predictive formulas, largely derived from western population, require validation in indians hence this study aims to establish a reliable, population-specific model for accurate SSD estimation.

A prospective observational study will be conducted at hospitals attached to BMCRI form febrauary 2026 to april 2026  to determine skin to subarachnoid space depth in indian adults undergoing spinal anaesthesia and to assess the accuracy of anthropometric data (height, weight,BMI,BSA) will be  collected and actual SSD will be  measured during midline lumbar puncture. Predicted SSDs will be  calculated using existing and newly derived equations to validate populaton- specific accuracy and improve procedural precision and safety.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA grade I/II patients posted for various elective surgeries under spinal anaesthesia in general, gynecology and obstetrics surgery unit.

Exclusion Criteria

  • •1.Patients with known hypersensitivity/contraindication to study drugs.
  • •2.Patients with coagulation disorders, infection at the site of spinal injection.
  • •3.Patients with severe renal/hepatic/respiratory or cardiac disease.
  • •4.Pregnant patients with hypertensive disorders/in patients where paramedian approach of spinal anaesthesia will be used.
  • •5.Patients with neurological/psychiatric/neuromuscular disorders/spine anomaly.
  • •6.associated medical illness with relative contraindication to spinal anaesthesia.

Outcomes

Primary Outcomes

1. correlation between subarachanoid space depth estimation by derived formula and the actual measurement at lumbar region in patients (males, females and pregnant women) undergoing spinal anesthesia."

Time Frame: at baseline and immediate after giving spinal anaesthesia

2.validation of the formulas derived from the previous study by using sensitivity analysis in patients (males, females and pregnant women) undergoing spinal anesthesia.

Time Frame: at baseline and immediate after giving spinal anaesthesia

Secondary Outcomes

  • Derivation of appropriate formula for subarachanoid space depth calculation based on height, weight, BMI and BSA from the data obtained from this study.(within 1 minute of giving spinal anesthesia n)

Investigators

Sponsor
Bangalore medical college and research institute
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DR YATHISH S K

Bangalore medical college and research institute

Study Sites (1)

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