NCT03805906

Brief Summary

This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

January 13, 2019

Last Update Submit

September 11, 2020

Conditions

Pain, Back

Outcome Measures

Primary Outcomes (1)

  • Block accuracy

    contrast distribution

    Immediately post-injection

Secondary Outcomes (2)

  • Performance time

    Perioperative

  • Number of needle passes

    Procedure

Study Arms (1)

Primary group

Ultrasound-Guided L5 Dorsal ramus block

Procedure: L5 Dorsal ramus block

Interventions

L5 Dorsal ramus blockPROCEDURE

Ultrasound-guided L5 dorsal ramus block

Primary group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus

You may qualify if:

  • Any consenting patient over 18 years of age with axial low back pain who requires a diagnostic L5 dorsal ramus block.

You may not qualify if:

  • Inability to consent
  • Iodine or lidocaine allergy,
  • Pregnancy,
  • Coagulopathy (as defined by an INR over 1.4, platelets under 100,000, or a documented bleeding disorder)
  • Inability to visualize lumbosacral anatomy during an ultrasound pre- scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Related Publications (1)

  • Etheridge JB, De Villiers F, Venter J, Squire P, Farnquist B, Finlayson RJ. Ultrasound-guided L5 dorsal ramus block: validation of a novel technique. Reg Anesth Pain Med. 2020 Mar;45(3):176-179. doi: 10.1136/rapm-2019-100783. Epub 2019 Oct 25.

    PMID: 31653796DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 16, 2019

Study Start

January 12, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)