Prospective Clinical Evaluation of BD Spinal Needles

Study Overview
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Brief Summary
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Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.

Detailed Description
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Single-arm, post-market, observational, prospective study of participants who will receive neuraxial procedures with a BD Spinal Needle as part of their routine medical care. Patients will be followed from BD Spinal needle insertion up to 7 days after the insertion according to the routine medical care and site policy. Data collected will be gathered from the patient's medical charts.

Official Title
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Prospective Clinical Evaluation of BD Spinal Needles

Conditions
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Analgesia, Anesthesia

Intervention / Treatment
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* Device: Spinal needle


Participation Criteria
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Eligibility Criteria
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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 Spinal Needles as part of their routine medical care Expected to be available for observation through the study period (7-days post procedure) Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.) Exclusion Criteria: Undergoing emergency surgery Coagulopathy or bleeding disorder for which regional anesthesia poses an increased risk History of neurological impairment or disease of the trunk or lower extremities. Infection at or near the site of needle insertion Previous spine surgery at the level involved in the study procedure
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants who require a BD Spinal needle | Device: Spinal needle<br>* Insertion of a spinal needle to perform the neuraxial procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-dural puncture headache (PDPH) | Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure | From insertion up to 7 days post procedure | 
| Incidence of successful needle placement | Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub. | During the insertion procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any needle or procedure-related spinal/epidural hematoma | Incidence of device/procedure-related adverse events including spinal/epidural hematoma | From insertion up to 7 days post procedure | 
| Incidence of any needle or procedure-related nerve damage (pain or weakness lower extremities) | Incidence of device/procedure-related adverse events including nerve damage (pain or weakness lower extremities) | From insertion up to 7 days post procedure | 
| Incidence of any needle or procedure-related infection (meningitis, spinal abscess) | Incidence of device/procedure-related adverse events including infection (meningitis, spinal abscess) | From insertion up to 7 days post procedure | 
| Incidence of any needle or procedure-related pain, skin redness, irritation at or near the skin puncture site | Incidence of device/procedure-related adverse events including pain, skin redness, irritation at or near the skin puncture site | From insertion up to 7 days post procedure | 
| Incidence of any needle or procedure-related backache | Incidence of device/procedure-related adverse events including backache | From insertion up to 7 days post procedure |