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| Name | Class |
|---|---|
| Walter Reed National Military Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation | Experimental | Pt will receive sedation with their procedure |
|
| Control | No Intervention | Patient will not receive sedation during procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Used for anxiolysis |
| |
| Fentanyl |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven P Cohen, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Blaustein Pain Treatment Center | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18042881 | Background | 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. | |
| 24524866 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedation | Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments". Sympathetic block: Sympathetic block with bupivacaine bupivacaine corticosteroid |
| FG001 | Control | Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedation | Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments". Sympathetic block: Sympathetic block with bupivacaine bupivacaine corticosteroid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score | pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable | Posted | Mean | Standard Deviation | units on a scale | through 6 hours after injection |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedation | Pt received sedation with their procedure sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments". Sympathetic block: Sympathetic block with bupivacaine bupivacaine corticosteroid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Less than 1 day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Cohen | Johns Hopkins | 410-955-1818 | scohen40@jhmi.edu |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Used for analgesia and as a sedative |
|
| 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 |
| BG001 | Control | Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Pain Score | 0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain. | Posted | Mean | Standard Deviation | units on a scale | 1-month |
|
|
|
| Secondary | Procedure-related Pain Score | 0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
|
|
| Secondary | Oswestry Disability Index | Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability | Posted | Mean | Standard Deviation | units on a scale | 1-month |
|
|
|
| Secondary | Satisfaction | 5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied. | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
|
|
| 0 |
| 37 |
| 3 |
| 37 |
| EG001 | Control | Patient did not receive sedation during procedure | 0 | 36 | 6 | 36 |
| dysphagia | Gastrointestinal disorders | Systematic Assessment | Less than 1 day |
|
| Headache | Nervous system disorders | Systematic Assessment | Less than 1 day |
|
| Worse pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Less than 1 week |
|
| Weakness | Nervous system disorders | Systematic Assessment | Less than 1 day |
|
| Dizziness | General disorders | Systematic Assessment | Less than 1 day |
|
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| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |