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Completed

NCT Number: NCT02750436

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Ultrasound guided

Device

This group will be treated using an ultrasound imaging device

Other names: Ultrasound guided sacral lateral branch block

Fluoroscopy guided

Device

This group will be treated using a fluoroscopy imaging device

Other names: Fluoroscopically guided sacral lateral branch block

Primary outcomes

  1. Performance time

    Time frame: Duration of procedure (less than 20 minutes)

    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.

Secondary outcomes

  1. Change in pain numerical rating score from baseline

    Time frame: Baseline and 20 minutes after procedure

    The extent of anesthesia provided by the blocks will be assessed by probing structures known to be innervated by the lateral branches and L5 posterior root. Two pain measurements will be undertaken, before and 20 minutes after the injections. Pain reports will be quantified by using a numerical rating score.

Sponsors and collaborators

Lead sponsor

Montreal General Hospital

Other

Registry information

Official study title

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

Acronym: USGSLBB

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2016
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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