Effect of Sedation on Diagnostic Injections

Study Overview
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Brief Summary
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Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. Many factors may increase the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. Proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. The purpose of this study is to determine the effect of intravenous sedation on pain relief and the false-positive rate after diagnostic nerve blocks.

Detailed Description
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Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. The post-procedure pain data will be recorded in the same fashion as the initial nerve block. The second follow-up visit will be 4 weeks after the 2nd block.

Official Title
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Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections

Conditions
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Sacroiliac Joint Pain, Sympathetically Maintained Pain

Intervention / Treatment
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* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic pain > 4 weeks but < 10 years in duration Suspected SI joint or sympathetically-maintained pain based on history and physical exam May benefit from a sacroiliac joint or sympathetic block Pain on 0-10 NRS scale > 3/10 in intensity Exclusion Criteria: No previous interventional pain-alleviating injections for the same condition within the past 3 years Uncontrolled coagulopathy Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age Allergy to contrast dye or amide local anesthetics Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response Systemic infection Age < 18 or > 75 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedation<br>Pt will receive sedation with their procedure | Drug: Midazolam<br>* Used for anxiolysis<br>Drug: Fentanyl<br>* Used for analgesia and as a sedative<br>|
| No Intervention: Control<br>Patient will not receive sedation during procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable | through 6 hours after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | 0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain. | 1-month | 
| Procedure-related Pain Score | 0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable | 1 day | 
| Oswestry Disability Index | Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability | 1-month | 
| Satisfaction | 5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, sensitivity, specificity, validity, diagnostic injection