Effect of Sedation on Diagnostic Injections

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Walter Reed National Military Medical Center
• Treatments: Fentanyl; Midazolam

Criteria

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