Prospective Clinical Evaluation of BD Spinal Needles

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
All participants	Spinal needle	Participants who require a BD Spinal needle

Primary Outcome Measures

Name	Time	Method
Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).	From insertion up to 7 days post procedure	Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.
Primary Performance: Incidence of Successful Needle Placement	During the insertion procedure	Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.

Secondary Outcome Measures

Name	Time	Method
Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).	From insertion up to 7 days post procedure	Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).
Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.	From insertion up to 7 days post procedure	Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site.
Secondary Safety: Incidence of Any Needle or Procedure-related Backache.	From insertion up to 7 days post procedure	Incidence of device/procedure-related adverse events including the incidence of backache.
Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.	From insertion up to 7 days post procedure	Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.
Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)	From insertion up to 7 days post procedure	Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)

Locations (6): Charité Campus Benjamin Franklin
🇩🇪
Berlin, Germany
Universitätsklinikum Leipzig
🇩🇪
Leipzig, Germany
Hospital Universitario Quirónsalud Madrid
🇪🇸
Madrid, Spain
Medizinische Universität Wien
🇦🇹
Wien, Austria
Schulthess Klinik, Zürich
🇨🇭
Zürich, Switzerland
Sejnjoen Central Hospital
🇫🇮
Seinäjoki, Finland