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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350307
• Other study ID #: 2000023982
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Needle Injury
• Pain

Intervention

Device:
• 22-gauge needle
22-gauge Quincke needle used for epidural injection
• 25-gauge needle
25-gauge Quincke needle used for epidural injection

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	During the procedure
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	During the procedure