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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Needle Injury
• Intervention / Treatment: Device: 22-gauge needle; Device: 25-gauge needle

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 22-Gauge Arm; Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle	Device: 22-gauge needle; 22-gauge Quincke needle used for epidural injection; Device: 25-gauge needle; 25-gauge Quincke needle used for epidural injection
Active Comparator: 25-Gauge Arm; Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle	Device: 22-gauge needle; 22-gauge Quincke needle used for epidural injection; Device: 25-gauge needle; 25-gauge Quincke needle used for epidural injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Rothman Institute Orthopaedics
• Investigators: Principal Investigator: Robin Raju, DO, Yale University

Publications and helpful links

General Publications

• Raju R, Mehnert M, Stolzenberg D, Simon J, Conliffe T, Gehret J. 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. BMC Anesthesiol. 2020 Sep 3;20(1):222. doi: 10.1186/s12871-020-01137-0.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2000023982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes