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RECRUITING
NCT06666621
PHASE4

Endogenous Opioid Response to Injections

Sponsor: Middle Tennessee Research Institute

View on ClinicalTrials.gov

Summary

This study will study pain relief after spine injections that are used to guide care. Some improvements in pain from a procedure might be from placebo effect rather than the physiological effect of the procedure. The study will use naloxone to reverse the effect of the body's internal placebo system after a spine injection, so the placebo effect and the injection effect can be measured separately. This process may improve the understanding of spine injections and their ability to guide pain care.

Official title: Antagonism of Endogenous Opioids: Use in Interpretation of Injections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-08-22

Completion Date

2026-02

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

DRUG

Normal saline infusion

After assessment of response to lumbar medial branch block, 8 ml normal saline will be infused through IV over several minutes. 10 minutes will pass, and response to lumbar medial branch block procedure will be re-assessed. After this step, naloxone infusion will occur (see next intervention)

DRUG

Naloxone infusion

After infusion of normal saline and re-assessment of response to lumbar medial branch block procedure, 8 milligrams of naloxone will be infused over several minutes. Then after 10 minutes, response to lumbar medial branch block procedure will be re-reassessed for the final time.

Locations (1)

VA Tennessee Valley Healthcare System

Nashville, Tennessee, United States