FindTrial
Sign In

Study to Evaluate Safety and Clinical Performance of Medispine/Glospine Spinal Needle in Patients who Required Spinal Anesthesia.

A Prospective, Open Label, Multi-Center, Single Arm, Observational, Post Marketing Clinical Follow-Up Study to Evaluate Safety and Clinical Performance of Medispine/Glospine Spinal Needle in Patients who Required Spinal Anesthesia. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036398
Enrollment
178
Registered
2021-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O894- Spinal and epidural anesthesia-induced headache during the puerperium

Interventions

Intervention1: Medispine/ Glospine spinal needle (quincke bevel and pencil point): Dose: NA Frequency: NA Route of administration: Spinal Duration of therapy: as per SOC (Standard of Care) subject to

Sponsors

Global Medikit Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient aged greater of equal to 18 years at the time of enrolment 2. Patient or his/her legally authorized representative (LAR) (if applicable) agrees to provide written informed consent 3. Patient is willing to comply with clinical investigation plan (CIP) specified follow-up evaluations 4. In case of anesthetic procedure carried out for hip or lower extremity surgeries, patients with American Society of Anaesthesiologists (ASA) physical status I-III who are planned to undergo surgery with spinal anesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications for spinal anesthesia and lumbar puncture mentioned in the study devices Instructions For Use (IFU) 2. Prior sacral or lumbar spine surgery 3. History of migraines or chronic headaches or previous PDPH 4. History of neurological deficits 5. Severe hypovolemia 6. Agitation or delirium, impaired cognition or dementia 7. Currently participating in another clinical study with experimental drugs or devices 8. Active SARS-CoV-2 infection known to patient at the time of enrolment in the study or patients having signs and symptoms of SARS-Co V-2 infection at the time of enrolment

Design outcomes

Primary

MeasureTime frame
Incidence of PDPH will be determined by the investigator based on the definition of PDPH provided by the international classification of headache disorders (ICHD)-3 criteria.Timepoint: Time frame: 24 hours, 48 hours and 72 hours post-procedure, discharge, 1 week ± 1 day]—

Secondary

MeasureTime frame
Success rate at the first attempt of lumbar puncture Time taken for lumbar puncture Timepoint: 1 Week—

Countries

India

Contacts

Public ContactDr Jatin Soni

Eupraxia Centre For Clinical Excellence LLP

jsoni@eupraxiaconsulting.com9630635333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026