Clinical trial NCT01472835: Effect of Sedation on Diagnostic Injections
Official title: Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Pain
Sympathetically Maintained Pain
Keywords: sedation
sensitivity
specificity
validity
diagnostic injection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
First posted: 2011-11-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Pain Score
timeFrame: through 6 hours after injection
Secondary outcomes:
measure: Pain Score
timeFrame: 1-month
measure: Procedure-related Pain Score
timeFrame: 1 day
measure: Oswestry Disability Index
timeFrame: 1-month
measure: Satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Blaustein Pain Treatment Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven P Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen SP, Hurley RW. The ability of diagnostic spinal injections to predict surgical outcomes. Anesth Analg. 2007 Dec;105(6):1756-75, table of contents. doi: 10.1213/01.ane.0000287637.30163.a2.
citation: Cohen SP, Hameed H, Kurihara C, Pasquina PF, Patel AM, Babade M, Griffith SR, Erdek ME, Jamison DE, Hurley RW. The effect of sedation on the accuracy and treatment outcomes for diagnostic injections: a randomized, controlled, crossover study. Pain Med. 2014 Apr;15(4):588-602. doi: 10.1111/pme.12389. Epub 2014 Feb 13.