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A study to evaluate a new 3D-printed device for improving patient positioning while giving sedation medication through spinal cord

A Prospective Single Blinded Crossover Study to Evaluate the Efficacy of a Novel 3D Printed Device Compared to Conventional Means for Optimal Positioning of a Patient for Undergoing Neuraxial Anesthesia by Using Ultrasound Guided Measurement of the Interlinear Space. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/107131
Enrollment
100
Registered
2026-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 3D-printed positioning device: Use of novel 3D-printed positioning device to assist optimal patient positioning for neuraxial anesthesia for a period of 10 minutes Control Intervention1

Sponsors

Saveetha Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults more than 18 years,ASA I III, Willing to provide informed consent, No contraindications to neuraxial anesthesia, Cooperative patients

Exclusion criteria

Exclusion criteria: Age less than 18 years, ASA IV V,Severe spinal deformity,Infection at puncture site,Coagulopathy / anticoagulant use,Neurological disorders affecting assessment,Previous complications with neuraxial anesthesia

Design outcomes

Primary

MeasureTime frame
Interlaminar space measurement (ultrasound-guided),Number of attempts for successful neuraxial blockTimepoint: baseline, 1 hour

Secondary

MeasureTime frame
Patient comfort scores,Procedural success rate,Time taken for procedure,Complication ratesTimepoint: baseline, 1 hour

Countries

India

Contacts

Public ContactDr Sanjay

Saveetha medical college hospital

dr_yach@yahoo.co.in9790963362

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026