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Effect of Sedation on Diagnostic Injections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472835
First Posted: November 17, 2011
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University
April 25, 2011
November 17, 2011
March 19, 2014
June 16, 2014
December 15, 2016
March 2011
February 2013   (Final data collection date for primary outcome measure)
Pain Score [ Time Frame: through 6 hours after injection ]
pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable
Pain Score [ Time Frame: through 6 hours after injection ]
pain diary using 0-10 scale
Complete list of historical versions of study NCT01472835 on ClinicalTrials.gov Archive Site
  • Pain Score [ Time Frame: 1-month ]
    0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.
  • Procedure-related Pain Score [ Time Frame: 1 day ]
    0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable
  • Oswestry Disability Index [ Time Frame: 1-month ]
    Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability
  • Satisfaction [ Time Frame: 1 day ]
    5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.
  • Pain Score [ Time Frame: 1-month ]
    0-10 NRS scale
  • Procedure-related Pain Score [ Time Frame: Recorded immediately after injection ]
    0-10 scale
  • Oswestry Disability Index [ Time Frame: 1-month ]
    Measure of functional capacity
  • Satisfaction [ Time Frame: 6 hours post-procedure ]
    5-point Likert scale
Not Provided
Not Provided
 
Effect of Sedation on Diagnostic Injections
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Sacroiliac Joint Pain
  • Sympathetically Maintained Pain
  • Drug: Midazolam
    Used for anxiolysis
  • Drug: Fentanyl
    Used for analgesia and as a sedative
  • Experimental: Sedation
    Pt will receive sedation with their procedure
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl
  • No Intervention: Control
    Patient will not receive sedation during procedure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01472835
NA_00045905
No
Not Provided
Not Provided
Steven P. Cohen, Johns Hopkins University
Johns Hopkins University
Walter Reed National Military Medical Center
Principal Investigator: Steven P Cohen, MD Johns Hopkins University
Johns Hopkins University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP