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

Not Applicable

Completed

• Conditions: Back Pain
• Interventions: Device: Fluoroscopy guided; Device: Ultrasound guided

• Registration Number: NCT02750436
• Lead Sponsor: Montreal General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-17
• Study First Submitted QC: 2016-04-20
• Study Start: 2016-04-25
• Study First Posted: 2016-04-25
• Primary Completion: 2016-07-30
• Study Completion: 2016-07-30
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopy guided	Fluoroscopy guided	Fluoroscopically guided sacral lateral branch block
Ultrasound guided	Ultrasound guided	Ultrasound guided sacral lateral branch block

Primary Outcome Measures

Name	Time	Method
Performance time	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 Outcome Measures

Name	Time	Method
Change in pain numerical rating score from baseline	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.

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada