Effect of Sedation on Diagnostic Injections

Sacroiliac Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472835
• Other study ID #: NA_00045905
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: May 19, 2014
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2011
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sacroiliac Joint Pain
• Sympathetically Maintained Pain

Intervention

Drug:
• Midazolam
Used for anxiolysis
• Fentanyl
Used for analgesia and as a sedative

Locations

Country	Name	City	State
United States	Johns Hopkins Blaustein Pain Treatment Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain Score	0-10 numerical rating scale (NRS) pain scale	1-month	No
Secondary	Procedure-related Pain Score	0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable	1 day	No
Secondary	Oswestry Disability Index	Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability	1-month	No
Secondary	Satisfaction	5-point Likert scale	1 day	No