Liza Smigel, M.D.
Hilo, Hawaii, 96720, United States
NCT Number: NCT01547364
Objective: The purposes of the study are to
1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline. 2. Determine if cumulative benefit results from caudal dextrose injection. 3. Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Hilo, Hawaii, 96720, United States
Injection of dextrose into the epidural space as an admixture with various steroids and anesthetic has been utilized for years for purposes of altering the specific gravity of the injectate. No safety issues or concerns have been raised about the dextrose component inclusion but a separate therapeutic effect of dextrose has not heretofore been considered. Recently dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). An analgesic effect of dextrose on chronic pain in the presence of painful sensory nerves has been observed with injection of D5W without anesthetic. That effect begins within seconds clinically. Physicians have empirically trialed D5W for epidural injection in a 10 ml volume and found that marked or complete analgesia of chronic low back and leg pain results in the majority of patients within 15 minutes. An empirical consecutive patient date collection has demonstrated that this initial effect lasts for 2 to 48 hours, and that the effect begins to sustain after 2-3 sessions. For this reason, the current study is designed with the the first two objectives:
In addition to determining potential benefit from caudal epidural of dextrose, the accuracy of a simple vertical approach to injection of dextrose is to be evaluated. If this vertical approach is accurate it will allow for
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of 10 ml of normal saline into the caudal epidural space
Other names: Normal Saline
Injection of 10 ml or dextrose 5% in water into the caudal epidural space
Other names: D5W
Time frame: 20 minutes
Caudal epidural injection of D5W will result in more analgesia at 20 minutes than epidural injection of normal saline.
Time frame: 1 year
Those with consistent analgesia after caudal epidural dextrose will note cumulative benefit on pain and disability that will exceed 1.5 times the MCID for pain and disability in low back pain. (NRS change of 3 or more)
Time frame: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.
Blind use of the Rosen technique for vertical short needle caudal epidural injection will produce an epidurogram pattern 80% of the time upon first needle placement.
Smigel, Liza, M.D.
Indiv
Blinded Analgesic Effect and 1 Year Outcome of Caudal D5W Injection in All-Comers With Chronic Low Back Pain and Either Buttock or Leg Pain
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