Effect of Sedation on Diagnostic Injections

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01472835
First received: April 25, 2011
Last updated: May 19, 2014
Last verified: April 2011
  Purpose

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 Intervention
Sacroiliac Joint Pain
Sympathetically Maintained Pain
Drug: Midazolam
Drug: Fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Pain Score [ Time Frame: through 6 hours after injection ] [ Designated as safety issue: No ]
    pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable


Secondary Outcome Measures:
  • Pain Score [ Time Frame: 1-month ] [ Designated as safety issue: No ]
    0-10 numerical rating scale (NRS) pain scale

  • Procedure-related Pain Score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable

  • Oswestry Disability Index [ Time Frame: 1-month ] [ Designated as safety issue: No ]
    Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability

  • Satisfaction [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    5-point Likert scale


Enrollment: 73
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472835

Locations
United States, Maryland
Johns Hopkins Blaustein Pain Treatment Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Steven P Cohen, MD Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven P. Cohen, Johns Hopkins Medical Institutions
ClinicalTrials.gov Identifier: NCT01472835     History of Changes
Other Study ID Numbers: NA_00045905
Study First Received: April 25, 2011
Results First Received: March 19, 2014
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
sedation
sensitivity
specificity
validity
diagnostic injection

ClinicalTrials.gov processed this record on September 18, 2014