Effect of Sedation on Diagnostic Injections
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/30/2013 |
Start Date: | March 2011 |
End Date: | December 2012 |
Contact: | Steven P Cohen, MD |
Email: | scohen40@jhmi.edu |
Phone: | 410-955-1822 |
Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections
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.
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.
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
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