Multi-center, prospective, open label, single arm post-market study to assess the real-world safety and efficacy of BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes used in an on-market fashion.
Who can participate
SexALL
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Inclusion criteria
✓. Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.
✓. Expected to be available for observation through the study period (10 days, ± 3 days, post procedure\*).
âś“. Able and willing to provide signed and dated informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant (Note: Consent of guardian or parent may be required for participants under the age of 18 years; participant assent may be required as well).
Exclusion criteria
âś•. Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk.
âś•. Subjects with a history of neurological impairment of the trunk or lower extremities.
âś•. Infection at the site of needle insertion.
âś•. Previous spine surgery at the level involved in the study procedure.
What they're measuring
1
Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location
Timeframe: During insertion procedure
2
Primary Performance: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used
Timeframe: During insertion procedure
3
Primary Performance: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes
Timeframe: During insertion procedure
4
Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration
Timeframe: During insertion procedure
5
Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH)
Timeframe: From insertion up to 10 (± 3 days) post procedure
6
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events
Timeframe: From insertion up to 10 (± 3 days) post procedure
7
Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes