Clinical trial NCT05214560: Prospective Clinical Evaluation of BD Spinal Needles
Official title: Prospective Clinical Evaluation of BD Spinal Needles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Anesthesia
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
Collaborators: name: Cromsource
First posted: 2022-01-28
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any participants who require a spinal needle device as part of their routine medical care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).
timeFrame: From insertion up to 7 days post procedure
measure: Primary Performance: Incidence of Successful Needle Placement
timeFrame: During the insertion procedure
Secondary outcomes:
measure: Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.
timeFrame: From insertion up to 7 days post procedure
measure: Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).
timeFrame: From insertion up to 7 days post procedure
measure: Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)
timeFrame: From insertion up to 7 days post procedure
measure: Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.
timeFrame: From insertion up to 7 days post procedure
measure: Secondary Safety: Incidence of Any Needle or Procedure-related Backache.
timeFrame: From insertion up to 7 days post procedure
Other outcomes:
measure: Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey.
timeFrame: After spinal needle placement
measure: Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.
timeFrame: After spinal needle placement
measure: Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.
timeFrame: After spinal needle placement
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Seinäjoki
country: Finland
facility: Sejnjoen Central Hospital
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
city: Zürich
country: Switzerland
facility: Schulthess Klinik, Zürich
Study officials:
affiliation: Becton, Dickinson and Company
name: Klaus Hoerauf, MD
role: STUDY_DIRECTOR
References: