A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks

NCT02750436 | Completed

• 1 other identifier: 15-544MUHC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• Performance time

  Block performance time will be measured from the time the first image is acquired, until the last injection is completed. Typical performance time are expected to be less than 20 minutes for both groups.

  Duration of procedure (less than 20 minutes)

Secondary Outcomes (1)

• Change in pain numerical rating score from baseline

  Baseline and 20 minutes after procedure

Study Arms (2)

Ultrasound guided

EXPERIMENTAL

Ultrasound guided sacral lateral branch block

Device: Ultrasound guided

Fluoroscopy guided

ACTIVE COMPARATOR

Fluoroscopically guided sacral lateral branch block

Device: Fluoroscopy guided

Interventions

Ultrasound guided DEVICE

This group will be treated using an ultrasound imaging device

Also known as: Ultrasound guided sacral lateral branch block

Ultrasound guided

Fluoroscopy guided DEVICE

This group will be treated using a fluoroscopy imaging device

Also known as: Fluoroscopically guided sacral lateral branch block

Fluoroscopy guided

Eligibility Criteria

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

You may qualify if:

• Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.

You may not qualify if:

• Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.

Sponsors & Collaborators

• Montreal General Hospital: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Roderick J Finlayson, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Anesthesia

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: April 25, 2016
• Study Start: April 25, 2016
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)