Efficacy of Ketamine, in the treatment of chronic pain with inflammatory component, evaluated in a double-blind, placebo-controlled trial.

Phase 1

Conditions: The population selected is a spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months) Adult, spinal cord injury (SCI), with <C5 involvement, presenting with chronic neuropathic pain ( DN), in lesional territory or under lesion. 2 groups: BM with DN with ulcer pressure (inflammation factor) BM with DN without ulcer pressure (without inflammation)
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2017-003930-10-FR

Lead Sponsor: Recherche et enseignement en douleur, anesthesie reanimation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 48

Inclusion Criteria

- Adults speaking and understanding French
- presenting chronic neuropathic pain as defined by IASP
- Painful intensity> or = to 6/10 during the week preceding the inclusion
- Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state.
- Able to give informed consent, after clear, fair and appropriate information
- Having given their consent by a written consent signature.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- Participation in another interventional trial, or participation in another trial that has been interrupted for less than 3 months.
- Patient under legal protection
- Pregnancy or breastfeeding
- Refusal to sign the consent
- Cardiovascular diseases associated in particular with disorders of rhythm and severe cardiac insufficiency, coronary insufficiency, discovered on examination, on ECG or by biological balance or known.
- unstabilized HTA> 180/100 mmHg
- Severe hepatic and / or renal hepatic insufficiency.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show improved clinical efficacy of ketamine in chronic pain in patients with an inflammatory component;Secondary Objective: To explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.;Primary end point(s): Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points at H4. Comparison of groups two by two.;Timepoint(s) of evaluation of this end point: 4 hours after infusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NPSI score at H1, H6, J1, J4, J7<br>Sub score of NPSI; H1, H6, J1, J4, J7<br>Depression score HADS J0, J1, J7<br>Painful surface evaluated on cartography H1, H4, J1, J4, J7<br><br>Blood tests in pre-administration of Ketamine and H6 after administration of: serotonin (5-HT), kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (KYN / TRP ratio), kynurenic acid (KA) and quinolinic acid (QA), as well as 3 proinflammatory cytokines IL-1ß, IL-6, and TNF-a;Timepoint(s) of evaluation of this end point: Hours 1 and 4<br>Day 1 4 and 7