Prospective Clinical Evaluation of BD Spinal Needles

Becton, Dickinson and Company160 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Analgesia Anesthesia

Interventions

Spinal needleDEVICE

Insertion of a spinal needle to perform the neuraxial procedure.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (6)

Medizinische Universität Wien

Vienna, Austria

Sejnjoen Central Hospital

Seinäjoki, Finland

Charité Campus Benjamin Franklin

Berlin, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).

Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.

Time frame: From insertion up to 7 days post procedure

Primary Performance: Incidence of Successful Needle Placement

Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.

Time frame: During the insertion procedure

Secondary Outcomes

Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.

Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.

Time frame: From insertion up to 7 days post procedure

Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).

Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).

Time frame: From insertion up to 7 days post procedure

Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)

Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)

Time frame: From insertion up to 7 days post procedure

Secondary Safety: 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 the incidence of any pain, skin redness, irritation at or near the skin puncture site.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.