Effect of Sedation on Diagnostic Injections

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. Identifier: NCT01472835
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : June 16, 2014
Last Update Posted : December 15, 2016
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Pain Sympathetically Maintained Pain Drug: Midazolam Drug: Fentanyl Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections
Study Start Date : March 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Sedation
Pt will receive sedation with their procedure
Drug: Midazolam
Used for anxiolysis
Drug: Fentanyl
Used for analgesia and as a sedative
No Intervention: Control
Patient will not receive sedation during procedure

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. Procedure-related Pain Score [ Time Frame: 1 day ]
    0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable

  3. Oswestry Disability Index [ Time Frame: 1-month ]
    Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability

  4. Satisfaction [ Time Frame: 1 day ]
    5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472835

United States, Maryland
Johns Hopkins Blaustein Pain Treatment Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Walter Reed National Military Medical Center
Principal Investigator: Steven P Cohen, MD Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven P. Cohen, Professor, Johns Hopkins University Identifier: NCT01472835     History of Changes
Other Study ID Numbers: NA_00045905
First Posted: November 17, 2011    Key Record Dates
Results First Posted: June 16, 2014
Last Update Posted: December 15, 2016
Last Verified: October 2016

Keywords provided by Steven P. Cohen, Johns Hopkins University:
diagnostic injection

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action