Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Study Overview
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Brief Summary
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The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Detailed Description
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Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain. Objectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain. Interventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.

Official Title
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Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Drug: oxytocin 100 micrograms
* Drug: Normal Saline (preservative free)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight < or equal to 240 pounds Neuropathic pain for > 6 months: with primary pain area below the umbilicus Exclusion Criteria: Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data Pregnancy spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for > 3 months at a current dose of > 100 milligram (mg) morphine per day or equivalent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin, then Placebo<br>The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT. | Drug: oxytocin 100 micrograms<br>* oxytocin 100 micrograms administered intrathecally (IT)<br>Drug: Normal Saline (preservative free)<br>* Normal Saline (preservative free) administered intrathecally (IT)<br>|
| Experimental: Placebo, then Oxytocin<br>The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT. | Drug: oxytocin 100 micrograms<br>* oxytocin 100 micrograms administered intrathecally (IT)<br>Drug: Normal Saline (preservative free)<br>* Normal Saline (preservative free) administered intrathecally (IT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous Pain From Their Neuropathic Pain Disease | Pain will be measured by visual analog scale, a 10 cm line with 0/no pain on the left end and 10/pain as worse as can be on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the no pain end. | 240 minutes post injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, neuropathic pain