N/A
N=160
Prospective Clinical Evaluation of BD Spinal Needles
Analgesia · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT05214560 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). — 2.8 % of subjects with a PDPH
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spinal needle (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Becton, Dickinson and Company
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). |
2.8 | — |
| PRIMARY Primary Performance: Incidence of Successful Needle Placement |
98.6 | — |
| SECONDARY Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. |
0.0 | — |
| SECONDARY Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). |
0.0 | — |
| SECONDARY Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) |
0.0 | — |
| SECONDARY Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. |
1.4 | — |
| SECONDARY Secondary Safety: Incidence of Any Needle or Procedure-related Backache. |
0.7 | — |
Summary
Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.
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
Data sourced from ClinicalTrials.gov (NCT05214560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.