Analgesia, Anesthesia
Conditions
Brief summary
Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.
Detailed 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.
Interventions
DEVICESpinal needle
Insertion of a spinal needle to perform the neuraxial procedure.
Sponsors
Cromsource
Becton, Dickinson and Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance: Incidence of Successful Needle Placement | During the insertion procedure | Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub. |
| Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | From insertion up to 7 days post procedure | Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). | From insertion up to 7 days post procedure | Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities). |
| Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess) |
| Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma. |
| Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site. |
| Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | From insertion up to 7 days post procedure | Incidence of device/procedure-related adverse events including the incidence of backache. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | After spinal needle placement | After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure. When the BD ancillary devices (e.g., spinal introducer) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance. |
| Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey. | After spinal needle placement | After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure. The ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance. |
| Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | After spinal needle placement | After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure. When the BD ancillary devices (e.g., BD syringe) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance. |
Countries
Austria, Finland, Germany, Spain, Switzerland
Participant flow
Recruitment details
The study was conducted at 6 sites in 5 European countries. The first participant was enrolled on February 14, 2022 and the last participant had the last study visit on July 22,2022.
Pre-assignment details
The choice of the specific BD Spinal Needle type, size, and length required for an individual participant was left to the discretion of the clinician. In this post market study, 160 participants, who were to receive a neuraxial procedures with a BD Spinal Needle as per routine clinical practice, were observed through 7-days post procedure to assess for adverse events/complications.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants who require a BD Spinal needle as part of their routine medical care.
Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice. | 144 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Anesthesia rejected by the patient on the day of surgery | 1 |
| Overall Study | Device not listed in the study was used for the procedure | 1 |
| Overall Study | General anesthesia at the request of the surgeon | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Screening Failure | 1 |
| Overall Study | Study physician not available for the anesthesia | 3 |
| Overall Study | Surgery not performed | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 18.01 |
| American Society of Anesthesiologists (ASA) physical status (PS) classification ASA PS Classification I | 39 Participants |
| American Society of Anesthesiologists (ASA) physical status (PS) classification ASA PS Classification II | 82 Participants |
| American Society of Anesthesiologists (ASA) physical status (PS) classification ASA PS Classification III | 23 Participants |
| Body Max Index | 27.51 kg/m^2 STANDARD_DEVIATION 4.934 |
| Primary diagnosis for intervention Obstetric | 5 Participants |
| Primary diagnosis for intervention Other | 47 Participants |
| Primary diagnosis for intervention Surgery of hips and pelvis | 9 Participants |
| Primary diagnosis for intervention Surgery of lower abdomen | 16 Participants |
| Primary diagnosis for intervention Surgery of lower extremities | 65 Participants |
| Primary diagnosis for intervention Surgery of perineum | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 143 Participants |
| Reason for neuraxial procedure Reason for neuraxial procedure:analgesia | 0 Participants |
| Reason for neuraxial procedure Reason for neuraxial procedure:anesthesia | 144 Participants |
| Reason for neuraxial procedure Reason for neuraxial procedure: other | 0 Participants |
| Region of Enrollment Austria | 5 participants |
| Region of Enrollment Finland | 35 participants |
| Region of Enrollment Germany | 73 participants |
| Region of Enrollment Spain | 31 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 92 Participants |
| Spinal needle placement details - Aseptic technique Aseptic technique = Betadine | 6 Participants |
| Spinal needle placement details - Aseptic technique Aseptic technique = Chlorhexidine | 26 Participants |
| Spinal needle placement details - Aseptic technique Aseptic technique = Other | 112 Participants |
| Spinal needle placement details - BD Spinal needle type BD Spinal Quincke needle 22Gx90mm | 5 Participants |
| Spinal needle placement details - BD Spinal needle type BD Spinal Quincke needle 27Gx90mm | 34 Participants |
| Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 25Gx103mm plus BD Introducer 20Gx32mm | 19 Participants |
| Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 25Gx90mm plus BD Introducer 20Gx32mm | 22 Participants |
| Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 27Gx103mm plus BD Introducer 22Gx32mm | 1 Participants |
| Spinal needle placement details - BD Spinal needle type BD Spinal Whitacre needle 27Gx90mm plus BD Introducer 22Gx32mm | 63 Participants |
| Spinal needle placement details - BD Syringes BD Syringe size 10mL used | 1 Participants |
| Spinal needle placement details - BD Syringes BD Syringe size 5mL used | 34 Participants |
| Spinal needle placement details - BD Syringes No BD Syringe used | 109 Participants |
| Spinal needle placement details - Local anesthesia Local anesthesia = Lidocaine 1% | 105 Participants |
| Spinal needle placement details - Local anesthesia Local anesthesia = Lidocaine 2% | 5 Participants |
| Spinal needle placement details - Local anesthesia Local anesthesia = Other | 34 Participants |
| Spinal needle placement details - Lumbar interspace L2-L3 | 12 Participants |
| Spinal needle placement details - Lumbar interspace L3-L4 | 104 Participants |
| Spinal needle placement details - Lumbar interspace L4-L5 | 27 Participants |
| Spinal needle placement details - Lumbar interspace Other | 1 Participants |
| Spinal needle placement details - Number of Interspace levels attempts Number of Interspace levels attempts = 1 | 132 Participants |
| Spinal needle placement details - Number of Interspace levels attempts Number of Interspace levels attempts = 2 | 10 Participants |
| Spinal needle placement details - Number of Interspace levels attempts Number of Interspace levels attempts = 3 | 2 Participants |
| Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 1 | 136 Participants |
| Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 2 | 3 Participants |
| Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 3 | 3 Participants |
| Spinal needle placement details - Number of Puncture attempts Number of Puncture attempts = 4 | 2 Participants |
| Spinal needle placement details - Paresthesia verbalized by participant Paresthesia not verbalized by participant | 138 Participants |
| Spinal needle placement details - Paresthesia verbalized by participant Paresthesia verbalized by participant | 6 Participants |
| Spinal needle placement details- Participant position during spinal needle procedure Lateral position | 39 Participants |
| Spinal needle placement details- Participant position during spinal needle procedure Sitting position | 105 Participants |
| Spinal needle placement details - Spontaneous appearance of CSF emerging from the needle hub No Spontaneous appearance of Cerebrospinal Fluid (CSF) emerging from the needle hub | 2 Participants |
| Spinal needle placement details - Spontaneous appearance of CSF emerging from the needle hub Spontaneous appearance of Cerebrospinal Fluid (CSF) emerging from the needle hub | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 144 |
| other Total, other adverse events | 17 / 144 |
| serious Total, serious adverse events | 0 / 144 |
Outcome results
Primary
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
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects: evaluable set, used for primary performance calculation.The study device could not be placed successfully in 1 subject due to pronounced left convex scoliosis and 1 subject with successful placement was not treated via the study device.142 subjects successfully received a placement of the study device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Primary Performance: Incidence of Successful Needle Placement | 98.6 % of successful needle placement |
Primary
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
Population: Out of 144 participants who received a neuraxial procedure, a total of 142 participants received a successful placement of the study device and were included in the safety set, used for the primary safety calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | 2.8 % of subjects with a PDPH |
Secondary
Secondary Safety: Incidence of Any Needle or Procedure-related Backache.
Incidence of device/procedure-related adverse events including the incidence of backache.
Time frame: From insertion up to 7 days post procedure
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | 0.7 % of subjects with backache |
Secondary
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
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | 0.0 % of subject with an infection |
Secondary
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
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). | 0.0 % of subject with a nerve damage |
Secondary
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.
Time frame: From insertion up to 7 days post procedure
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | 1.4 % subjects with pain/readness/irritation |
Secondary
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
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | 0.0 % of subject with a spinal hematoma |
Other Pre-specified
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.
After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure. When the BD ancillary devices (e.g., spinal introducer) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.
Time frame: After spinal needle placement
Population: Considering that the Spinal Introducer is an optional aid to perform the spinal procedure, 105 Introducers have been used by physicians to perform the study procedure, but only for 104 of 105 subjects for which the BD introducer has been used, the investigators completed the questionnaire and answered the respective question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | Use of the BD Introducer was easy or very easy | 104 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | PIs were agree with introducer facilitated placement of spinal needle | 103 Participants |
Other Pre-specified
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey.
After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure. The ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance.
Time frame: After spinal needle placement
Population: 160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for this specific measure. 143 is the overall number of subjects analyzed because 1 physician did not complete the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey. | BD Spinal Needle insertion was easy or very easy | 135 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey. | BD Spinal Needle withdrawal after placement was easy or very easy | 143 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey. | PIs were agree with stylet helped to determine the direction of spinal needle tip | 131 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey. | PIs were agree or strongly agree with stylet functioned properly during spinal needle placement. | 143 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey. | Ease of BD Stylet removal from the spinal needle after placement was easy or very easy | 142 Participants |
Other Pre-specified
Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.
After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure. When the BD ancillary devices (e.g., BD syringe) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.
Time frame: After spinal needle placement
Population: Considering that this study is an observational study in which the physicians performed the spinal procedure according to their clinical practice and hence, they could choose any ancillary devices to achieve the study procedure, 35 BD syringes have been used by physicians to perform the study procedure, and the investigators completed the questionnaire and answered the respective question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | Reading BD Syringe graduations when preparing the dose for spinal injection was very easy | 35 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | Securely connecting between the BD Syringe and the BD Spinal Needle hub was easy or very easy | 32 Participants |
| All Participants | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | Disconnecting the syringe from the spinal needle after injection was very easy | 31 Participants |