Prospective Clinical Evaluation of BD Spinal Needles

Anesthesia Clinical Trial

Official title:

Prospective Clinical Evaluation of BD Spinal Needles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214560
• Other study ID #: MDS-20EPSPEU001
• Status: Completed
• Start date: February 10, 2022
• Est. completion date: July 22, 2022

Study information

• Verified date: September 2022
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia

Intervention

Device:
• Spinal needle
Insertion of a spinal needle to perform the neuraxial procedure.

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien	Wien
Finland	Sejnjoen Central Hospital	Seinäjoki
Germany	Charité Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Leipzig	Leipzig
Spain	Hospital Universitario Quirónsalud Madrid	Madrid
Switzerland	Schulthess Klinik, Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Becton, Dickinson and Company	Cromsource

Countries where clinical trial is conducted

Austria,  Finland,  Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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