Effect of Sedation on Diagnostic Injections

NCT ID: NCT01472835

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Sacroiliac Joint Pain; Sympathetically Maintained Pain

Keywords

sedation; sensitivity; specificity; validity; diagnostic injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sedation

Pt will receive sedation with their procedure

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Used for anxiolysis

Fentanyl

Intervention Type: DRUG

Used for analgesia and as a sedative

Control

Patient will not receive sedation during procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Midazolam

Used for anxiolysis

Intervention Type: DRUG

Fentanyl

Used for analgesia and as a sedative

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Steven P. Cohen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven P Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Blaustein Pain Treatment Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18042881 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24524866 (View on PubMed)

Other Identifiers

NA_00045905

Identifier Type: -

Identifier Source: org_study_id