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

Not Applicable

Completed

• Conditions: Needle Injury; Pain
• Interventions: Device: 22-gauge needle; Device: 25-gauge needle

• Registration Number: NCT04350307
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-09-30
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Results First Submitted: 2020-05-30
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Results First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

1. patients with low back pain and/or radicular pain,
2. patients scheduled for lumbosacral TFESI.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25-Gauge Arm	22-gauge needle	Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
22-Gauge Arm	22-gauge needle	Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle
25-Gauge Arm	25-gauge needle	Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle
22-Gauge Arm	25-gauge needle	Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States