Analgesia, Anesthesia
Conditions
Brief summary
Multi-center, prospective, open label, single arm post-market study to assess the real-world safety and efficacy of BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes used in an on-market fashion.
Detailed description
This is a multi-center, prospective, open label, single arm post-market study that will enroll approximately 180 participants in order to have a minimum of 150 treated participants who will receive a spinal anesthesia procedure as part of their routine medical care. Participants will be followed from the time of enrollment for up to 10 days (± 3 days) post spinal anesthesia procedure for evidence of adverse events including Post Dural Puncture Headache (PDPH). This can be done via phone if the participant is discharged from the hospital. The site staff must take advantage of the time window of ± 3 days only when the 10-day post-procedure occurs during the weekends or holidays. Any adverse event or complication must be diagnosed and confirmed by a study physician. A minimum of 50 participants for each of the two needle tip types (Quincke and Whitacre tip) will be enrolled in the study.
Interventions
DEVICEBD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes
Insertion of a BD NRFit™ spinal needle and optional BD NRFit™ Spinal Introducer Needle using a BD NRFit™ Syringe to perform the neuraxial procedure.
Sponsors
Becton, Dickinson and Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location | During insertion procedure | Percentage of participants with successful placement of the BD Spinal NRFit™ needle in the subarachnoid location defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle hub. |
| Primary Performance: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used | During insertion procedure | Percentage of participants with successful placement of the BD Spinal NRFit™ needle in the subarachnoid location defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle hub when an BD NRFit™ introducer is used. |
| Primary Performance: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes | During insertion procedure | Percentage of participants with successful aspiration of anesthetic through a BD NRFit™ Syringe. |
| Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration | During insertion procedure | Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration. |
| Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) | From insertion up to 10 (± 3 days) post procedure | Percentage of participants with a diagnosis of PDPH (defined as headache that worsens when standing/upright position and relieves when laying supine) for a period of up to 10 (± 3 days) days following the procedure. |
| Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | From insertion up to 10 (± 3 days) post procedure | Percentage of participants with any device/procedure-related adverse events. |
| Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes | During the insertion procedure | Percentage of participants with successful injection of anesthetic through a BD NRFit™ Syringe. |
Countries
Austria, Germany, Spain
Participant flow
Recruitment details
The study was conducted at 5 sites in 3 European countries. The first participant was enrolled on July 24, 2023 and the last participant had the last study visit on June 07,2024.
Pre-assignment details
In this post-market study, the choice of BD Spinal NRFit™ needle (gauge, length, tip type), BD Syringes NRFit™, BD Spinal NRFit™ needle set, and BD Spinal Introducer NRFit™ needle was at clinician discretion. A total of 161 subjects were enrolled to ensure a minimum of 150 received spinal anesthesia and were observed for 10 days post-procedure for adverse events/complications. A minimum of 50 subjects per tip type (Quincke and Whitacre) were included.
Participants by arm
| Arm | Count |
|---|---|
| Treated Population Participants who underwent a neuraxial procedure, regardless of success. | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Screen Failure | 2 |
| Overall Study | Surgery cancelled | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Treated Population |
|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 17.28 |
| American Society of Anesthesiologists (ASA) Physical Status (PS) Classification I | 31 Participants |
| American Society of Anesthesiologists (ASA) Physical Status (PS) Classification II | 94 Participants |
| American Society of Anesthesiologists (ASA) Physical Status (PS) Classification III | 28 Participants |
| Ancillary device Usage BD Blunt Fill NRFit™ Needle | 79 Participants |
| Ancillary device Usage BD Blunt Filter NRFit™ Needle | 74 Participants |
| Anesthetic medication aspiration Anesthetic medication aspirated from ampule | 110 Participants |
| Anesthetic medication aspiration Anesthetic medication aspirated from vial | 43 Participants |
| Anesthetic medication injection through BD NRFit™ syringe Anesthetic medication successfully injected through BD NRFit™ syringe | 146 Participants |
| Anesthetic medication injection through BD NRFit™ syringe No anesthetic medication successfully injected through BD NRFit™ syringe | 7 Participants |
| Anesthetic medication successfully aspirated using the BD NRFit™ syringe | 153 Participants |
| Aseptic Technique Betadine | 10 Participants |
| Aseptic Technique Chlorohexidine | 43 Participants |
| Aseptic Technique Octenidine | 32 Participants |
| Aseptic Technique Other | 68 Participants |
| BD NRFit™ Syringe Usage BD Syringes NRFit™ Lok with a volume of 3 mL | 7 Participants |
| BD NRFit™ Syringe Usage BD Syringes NRFit™ Slip with a volume of 5 mL | 146 Participants |
| BD Spinal NRFit™ Needle Type BD Spinal NRFit™ Quincke Needle | 50 Participants |
| BD Spinal NRFit™ Needle Type BD Spinal NRFit™ Whitacre Needle | 103 Participants |
| Device Used BD Spinal NRFit™ Needle | 25 Participants |
| Device Used BD Spinal NRFit™ Needle Set | 128 Participants |
| Height | 172.3 cm STANDARD_DEVIATION 9.47 |
| Local Anaesthesia Lidocaine 1% | 113 Participants |
| Local Anaesthesia Lidocaine 2% | 35 Participants |
| Local Anaesthesia Other | 5 Participants |
| Lumbar interspace L2-3 | 12 Participants |
| Lumbar interspace L3-4 | 94 Participants |
| Lumbar interspace L4-5 | 44 Participants |
| Lumbar interspace Other | 3 Participants |
| Number of Puncture Attempts 1 | 142 Participants |
| Number of Puncture Attempts 2 | 10 Participants |
| Number of Puncture Attempts 3 | 1 Participants |
| Participant position during spinal anesthesia Lateral | 6 Participants |
| Participant position during spinal anesthesia Sitting | 147 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 149 Participants |
| Reason for Neuraxial Procedure: Anesthesia | 153 Participants |
| Reasons for Surgery Surgery of Hips and Pelvis | 18 Participants |
| Reasons for Surgery Surgery of Lower Abdomen | 40 Participants |
| Reasons for Surgery Surgery of Lower Extremities | 91 Participants |
| Reasons for Surgery Surgery of Perineum | 4 Participants |
| Region of Enrollment Austria | 59 participants |
| Region of Enrollment Germany | 49 participants |
| Region of Enrollment Spain | 45 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 95 Participants |
| Spontaneous appearance of CSF emerging from the needle hub No spontaneous appearance of CSF emerging from the needle hub | 7 Participants |
| Spontaneous appearance of CSF emerging from the needle hub Spontaneous appearance of CSF emerging from the needle hub | 146 Participants |
| Weight | 80.76 Kg STANDARD_DEVIATION 18.753 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 153 |
| other Total, other adverse events | 14 / 153 |
| serious Total, serious adverse events | 1 / 153 |
Outcome results
Primary
Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes
Percentage of participants with successful injection of anesthetic through a BD NRFit™ Syringe.
Time frame: During the insertion procedure
Population: All participants in whom a spinal anesthesia procedure is successful
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes | 146 Participants |
Primary
Primary Performance: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used
Percentage of participants with successful placement of the BD Spinal NRFit™ needle in the subarachnoid location defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle hub when an BD NRFit™ introducer is used.
Time frame: During insertion procedure
Population: All participants in whom a spinal anesthesia procedure is attempted using a BD NRFit™ Spinal Introducer, regardless of success.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Primary Performance: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used | 124 Participants |
Primary
Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration
Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.
Time frame: During insertion procedure
Population: All participants in whom a spinal anesthesia procedure is successful
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration | 145 Participants |
Primary
Primary Performance: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes
Percentage of participants with successful aspiration of anesthetic through a BD NRFit™ Syringe.
Time frame: During insertion procedure
Population: All participants in whom a spinal anesthesia procedure is attempted, regardless of success
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Primary Performance: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes | 153 Participants |
Primary
Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location
Percentage of participants with successful placement of the BD Spinal NRFit™ needle in the subarachnoid location defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle hub.
Time frame: During insertion procedure
Population: All participants in whom a spinal anesthesia procedure is attempted, regardless of success.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location | Rate of successful BD Spinal NRFit™ Needle placement in subarachnoid location | 146 Participants |
| All Participants | Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location | Rate of successful placement of BD Spinal NRFit™ Whitacre Needle in subarachnoid location | 100 Participants |
| All Participants | Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location | Rate of successful BD Spinal NRFit™ Quincke Needle placement in subarachnoid location | 46 Participants |
Primary
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events
Percentage of participants with any device/procedure-related adverse events.
Time frame: From insertion up to 10 (± 3 days) post procedure
Population: All participants in whom a spinal anesthesia procedure is attempted, regardless of success
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | Rate of participants with any BD NRFit™ spinal needle related adverse events (other than PDPH) | 0 Participants |
| All Participants | Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | Rate of participants with any BD NRFit™ introducer-related adverse events (other than PDPH) | 0 Participants |
| All Participants | Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | Rate of participants with any BD NRFit™ syringe-related adverse events (other than PDPH) | 0 Participants |
| All Participants | Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | Rate of participants with any procedure-related adverse events (other than PDPH) | 6 Participants |
| All Participants | Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | Rate of participants with any BD NRFit™spinal needle, introducer, syringe, or procedure-related AEs | 6 Participants |
Primary
Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH)
Percentage of participants with a diagnosis of PDPH (defined as headache that worsens when standing/upright position and relieves when laying supine) for a period of up to 10 (± 3 days) days following the procedure.
Time frame: From insertion up to 10 (± 3 days) post procedure
Population: All participants in whom a spinal anesthesia procedure is successful
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) | Rate of post dural puncture headache (PDPH) for Subjects Using Whitacre Needle | 1 Participants |
| All Participants | Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) | Rate of post dural puncture headache (PDPH) for Subjects Using Quincke Needle | 2 Participants |
| All Participants | Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) | Rate of post dural puncture headache (PDPH) | 3 Participants |