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

Not Applicable

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

• Registration Number: CTRI/2021/09/036398
• Lead Sponsor: Global Medikit Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified