Comparison of Intravascular Uptake and Pain Perception During Epidural Injection Using 22 Gauge vs 25 Gauge Needle

Study Overview
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Brief Summary
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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
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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.

Official Title
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Differential Rates of Intravascular Uptake and Pain Perception During Lumbosacral Transforaminal Epidural Steroid Injection Using a 22-gauge Needle Versus 25-gauge Needle

Conditions
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Pain, Needle Injury

Intervention / Treatment
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* Device: 22-gauge needle
* Device: 25-gauge needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with low back pain and/or radicular pain, patients scheduled for lumbosacral TFESI. Exclusion Criteria: patients with contrast/local anesthetic allergy, patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent, vulnerable patient population including prisoners, patients with severe anxiety, patients with prior lumbar surgery, age <18 years old, and Body Mass Index (BMI) > 40.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a prospective single blind randomized clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 22-Gauge Arm<br>Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle | Device: 22-gauge needle<br>* 22-gauge Quincke needle used for epidural injection<br>Device: 25-gauge needle<br>* 25-gauge Quincke needle used for epidural injection<br>|
| Active Comparator: 25-Gauge Arm<br>Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle | Device: 22-gauge needle<br>* 22-gauge Quincke needle used for epidural injection<br>Device: 25-gauge needle<br>* 25-gauge Quincke needle used for epidural injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During the procedure |