New spinal needles and syringes tested in Real-World use
NCT ID NCT05953363
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested how well BD NRFit spinal needles and syringes work in real-world medical settings. A total of 161 patients receiving anesthesia or pain relief procedures were included. Researchers measured successful needle placement, syringe function, and safety issues like headaches. The goal was to confirm the devices perform as expected in routine care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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161 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Jun 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects who will receive a spinal anesthesia procedure as part of their routine medical care.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care. 2. Expected to be available for observation through the study period (10 days, ± 3 days, post procedure\*). 3. Able and willing to provide signed and dated informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant (Note: Consent of guardian or parent may be required for participants under the age of 18 years; participant assent may be required as well). Exclusion Criteria: 1. Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk. 2. Subjects with a history of neurological impairment of the trunk or lower extremities. 3. Infection at the site of needle insertion. 4. Previous spine surgery at the level involved in the study procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barmherzige Bruder Krankenhaus Salzburg
Salzburg, Austria
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Charité Campus Benjamin Franklin
Berlin, Germany
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Hospital Universitario Quirónsalud Madrid
Madrid, Spain
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Medizinische Universität Wien
Vienna, Austria
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Universitätsklinikum Leipzig
Leipzig, Germany
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Other studies related to the condition(s) this trial covers.
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