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Completed

NCT Number: NCT01472835

Effect of Sedation on 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Blaustein Pain Treatment Center

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Used for anxiolysis

Fentanyl

Drug

Used for analgesia and as a sedative

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Walter Reed National Military Medical Center

Registry information

Official study title

Randomized, Cross-over Study Evaluating the Effect of Sedation on Pain Relief After Diagnostic Injections

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2011
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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