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

NCT04350307 | Completed Results FDA Device

• 1 other identifier: 2000023982
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Needle Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Reported Pain

  During the procedure

Study Arms (2)

22-Gauge Arm

ACTIVE COMPARATOR

Patient undergoing epidural injection in this arm will get 22-gauge Quincke needle

Device: 22-gauge needle; Device: 25-gauge needle

25-Gauge Arm

ACTIVE COMPARATOR

Patient undergoing epidural injection in this arm will get 25-gauge Quincke needle

Device: 22-gauge needle; Device: 25-gauge needle

Interventions

22-gauge needle DEVICE

22-gauge Quincke needle used for epidural injection

22-Gauge Arm; 25-Gauge Arm

25-gauge needle DEVICE

25-gauge Quincke needle used for epidural injection

22-Gauge Arm; 25-Gauge Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with contrast/local anesthetic allergy,
• patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent,
• vulnerable patient population including prisoners,
• patients with severe anxiety,
• patients with prior lumbar surgery,
• age \<18 years old, and
• Body Mass Index (BMI) \> 40.

Sponsors & Collaborators

• Yale University: lead
• Rothman Institute Orthopaedics: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  PMID: 32883241 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Robin Raju
• Organization: Yale University

robin.raju@yale.edu

203-688-8800

Study Officials

• Robin Raju, DO

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization was done separately for each provider based on a computer generated algorithm. Patients were blinded to the gauge of the needle used for the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: This was a prospective single blind randomized clinical trial.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: February 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 20, 2020
• Results First Posted: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)