Needle Injury, Pain
Conditions
Brief summary
The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral epidural steroid injection in regards to intravascular uptake and pain perception. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain.
Detailed description
Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.
Interventions
DEVICE22-gauge needle
22-gauge Quincke needle used for epidural injection
DEVICE25-gauge needle
25-gauge Quincke needle used for epidural injection
Sponsors
Rothman Institute Orthopaedics
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Randomization was done separately for each provider based on a computer generated algorithm. Patients were blinded to the gauge of the needle used for the procedure.
Intervention model description
This was a prospective single blind randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients with low back pain and/or radicular pain, 2. patients scheduled for lumbosacral TFESI.
Exclusion criteria
1. patients with contrast/local anesthetic allergy, 2. patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent, 3. vulnerable patient population including prisoners, 4. patients with severe anxiety, 5. patients with prior lumbar surgery, 6. age \<18 years old, and 7. Body Mass Index (BMI) \> 40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intravascular Uptake | During the procedure | The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain | During the procedure | Patient reported pain during the procedure (on initial needle entry) on the numerical rating scale (NRS 1-10). Higher numbers implies higher severity of pain. Lower numbers implies lower severity of pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 22-Gauge Arm Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
22-gauge needle: 22-gauge Quincke needle used for epidural injection | 84 |
| 25-Gauge Arm Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
25-gauge needle: 25-gauge Quincke needle used for epidural injection | 78 |
| Total | 162 |
Baseline characteristics
| Characteristic | 25-Gauge Arm | Total | 22-Gauge Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 58 Participants | 118 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 44 Participants | 24 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 3 | 58 years STANDARD_DEVIATION 2 | 60 years STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 78 participants | 162 participants | 84 participants |
| Sex: Female, Male Female | 37 Participants | 83 Participants | 46 Participants |
| Sex: Female, Male Male | 41 Participants | 79 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 78 |
| other Total, other adverse events | 0 / 84 | 0 / 78 |
| serious Total, serious adverse events | 0 / 84 | 0 / 78 |
Outcome results
Primary
Intravascular Uptake
The intravascular uptake percentage reported in the study is the percent of 'needles' that showed intravascular uptake. Hence higher 'intravascular uptake percentage' means worse outcome. The mean percentages were averaged across participants were compared between treatment arms. Presence or absence of intravascular uptake during live fluoroscopy and/or blood aspiration per needle. Once needle reached its target (epidural space), contrast was injected to confirm the presence or absence of intravascular uptake via live fluoroscopy or aspiration was attempted using a syringe to confirm the presence or absence of intravascular uptake. If contrast pattern suggested needle was in a vessel or blood was aspirated using a syringe, outcome measure was marked 'PRESENT'. If contrast pattern suggested needle was not in a vessel and no blood was aspirated using a syringe, outcome measure was marked 'ABSENT'. In other words, primary outcome measure was binary in nature.
Time frame: During the procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 22-Gauge Arm | Intravascular Uptake | 5.9 percentage of total number of needle |
| 25-Gauge Arm | Intravascular Uptake | 7.1 percentage of total number of needle |
Secondary
Patient Reported Pain
Patient reported pain during the procedure (on initial needle entry) on the numerical rating scale (NRS 1-10). Higher numbers implies higher severity of pain. Lower numbers implies lower severity of pain
Time frame: During the procedure
Population: Average NRS during the initial needle entry
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 22-Gauge Arm | Patient Reported Pain | 3.46 score on a scale |
| 25-Gauge Arm | Patient Reported Pain | 3.13 score on a scale |