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

Yale University162 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

162

Conditions

Pain Needle Injury

Interventions

22-gauge needleDEVICE

22-gauge Quincke needle used for epidural injection

25-gauge needleDEVICE

25-gauge Quincke needle used for epidural injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.