NCT04350307

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

Completed NA Results posted Last updated 20 July 2020

What this trial tests

NA trial testing 22-gauge needle in Pain in 162 participants. Completed in 30 September 2019.

Timeline

1 February 2018

Primary endpoint
30 June 2019

30 September 2019

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	162
Start date	1 February 2018
Primary completion	30 June 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

• 22-gauge needle
• 25-gauge needle

Conditions studied

• Pain — all drugs for Pain →
• Needle Injury — all drugs for Needle Injury →

Sponsor

Yale University

Who can join

18 and older, any sex, with Pain or Needle Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intravascular Uptake Primary · 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 pres

Group	Value	95% CI
22-Gauge Arm	5.9	1.9 – 9.8
25-Gauge Arm	7.1	2.4 – 11.8

Patient Reported Pain Secondary · 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

Group	Value	95% CI
22-Gauge Arm	3.46	2.94 – 3.98
25-Gauge Arm	3.13	2.57 – 3.69

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial.
   Raju R, Mehnert M, Stolzenberg D, Simon J, et al · · 2020 · cited 2× · PMID 32883241 · DOI 10.1186/s12871-020-01137-0