NCT01472835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 16, 2014

Completed
Last Updated

December 15, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

April 25, 2011

Results QC Date

March 19, 2014

Last Update Submit

October 31, 2016

Conditions

Sacroiliac Joint PainSympathetically Maintained Pain

Keywords

sedationsensitivityspecificityvaliditydiagnostic injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pain Score

    1-month

  • Procedure-related Pain Score

    1 day

  • Oswestry Disability Index

    1-month

  • Satisfaction

    1 day

Study Arms (2)

Sedation

EXPERIMENTAL

Pt will receive sedation with their procedure

Drug: MidazolamDrug: Fentanyl

Control

NO INTERVENTION

Patient will not receive sedation during procedure

Interventions

MidazolamDRUG

Used for anxiolysis

Sedation
FentanylDRUG

Used for analgesia and as a sedative

Sedation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Blaustein Pain Treatment Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • 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.

    PMID: 18042881BACKGROUND

  • 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.

    PMID: 24524866DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

MidazolamFentanyl

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Steven Cohen
Organization
Johns Hopkins
scohen40@jhmi.edu
410-955-1818

Study Officials

  • Steven P Cohen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2011

First Posted

November 17, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 15, 2016

Results First Posted

June 16, 2014

Record last verified: 2016-10

Locations

US(1)