N/A Completed N=73 Randomized Diagnostic

Effect of Sedation on Diagnostic Injections

Sacroiliac Joint Pain · Sympathetically Maintained Pain

Source: ClinicalTrials.gov NCT01472835 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcomePrimary: Pain Score — 2.2; 3.4 units on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Score	5.1; 5.6	—
SECONDARY Pain Score	5.1; 5.6	—
SECONDARY Procedure-related Pain Score	3.1; 5.5	—
SECONDARY Oswestry Disability Index	34.8; 40.6	—
SECONDARY Satisfaction	4.0; 3.6	—

Eligibility Criteria

Inclusion Criteria

Chronic pain > 4 weeks but 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 75 years

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Data sourced from ClinicalTrials.gov (NCT01472835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.