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.

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Pain; Sympathetically Maintained Pain
• Intervention / Treatment: Drug: Midazolam; Drug: Fentanyl

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
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Blaustein Pain Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Walter Reed National Military Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: validity; sedation; sensitivity; specificity; diagnostic injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam
• Other Study ID Numbers: NA_00045905