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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04350307
Other study ID # 2000023982
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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