Phantom limb pain MedDRA version: 14.1 Level: LLT Classification code 10034804 Term: Phantom limb pain System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Ketolar
Product Name: Ketamina
Product Code: Ketamina perineural
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ketamina
CAS Number: 79499-51-7
Current Sponsor code: keta
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Amputees above or under the knee ?Indication of amputation must be non-diabetic ischemic ?Phantom limb pain of at least 10 days and moderate to severe (visual analogue scale VAS> 5 in a period of 3 consecutive days) ?Adults over 18 y ?Informed consent ?Ability to answer the questionnaires of pain, function and quality of life 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: ? Prior amputation of the same or other limb ? Severe psychiatric illness including schizophrenia ? Contraindication to the use of ketamine ? Absolute contraindications for the performance of anesthetic blocks (infectious, hematologic) ? Patient compensation pending litigation related to the pathology ? Another type of chronic pain, especially neuropathic pain, which in the opinion of the investigator may interfere with the assessment by the patient ? States of generalized hyperalgesia, in the opinion of the investigator, may interfere with the assessment of pain (eg Fibromyalgia) ? Use of Opioids (Tramadol excluded if 900 mg / d or Pregabalin> 150 mg / d ? Use of Amitriptyline ? Uncontrolled hypertension ? Cranial hypertension ? Central Nervous System Neoplasms ? Diabetic neuropathy ? Electrocardiogram with alterations considered exclusive by the clinician (particularly long QTc) ? Children under 18 y ? Inability to respond to the scales
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether blocking NMDA receptors (N-methyl-D-aspartate) at peripheral perineural can reverse phantom limb pain. The molecular mechanisms of peripheral and central sensitization, necessarily involve the glutamate-NMDA system, which can be blocked by the anesthetic drug ketamine albeit at the expense of unacceptable side effects from excessive doses. His administration at low doses, but in the target organ may reduce these adverse reactions and be more effective.;Secondary Objective: ? Assessment of variability and maintenance of analgesic quality in 3 months follow-up ? Verify the existence of a parallel between the perineural blood flow and severity of pain and / or phantom limb sensation ? Assessment of the different profile of adverse reactions expected between intravenous administration and perineural ? Assessment of neuropathic pain descriptors items spontaneous and evoked, quality of life, depression and anxiety.;Primary end point(s): Improvement in phantom limb pain> 40% at 7 days after administration of perineural vs. perineural ketamine (Mean score in Visual Analog Scale in the last 24 h; VAS-24h);Timepoint(s) of evaluation of this end point: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Assessment of variability and maintenance of analgesic quality over time (mean VAS-24h score at 7 days - 1 month - 3 months) ? Analysis of the response to heat by Peltier probe (Thermotest-CHEPS) at the front of the arm before and 30 minutes after using the perineural blockade limits. Intra-and interindividual comparison in addition to our normal population. Repeated test at 7 days - 1 month - 3 months. This should give us information on the systemic antinocicetive response in addition to detecting basal central sensitization phenomena. ? Verify the existence of a parallelism between the perineural blood flow and severity of pain and / or phantom limb sensation, maximum flow rate measured by Doppler ultrasound in nerve trunks terminals (Basal - 7 days - 1 month - 3 months) ? Assessment of the different profile of adverse reactions expected between intravenous and perineural administration of ketamine: sedation (Ramsay), interrogation of tactile hallucinations, visual and auditory. ? Differences in other self-administered scale values (Basal - 7 days - 1 month - 3 months) ? Neuropathic pain questionnaire ? Depression and Anxiety Scale HADS ? EUROQOL-5D quality of life ? Patient and the clinician impression of change ? Phantom limb sensation questionnaire ? Description of changes in anatomical distortion;Timepoint(s) of evaluation of this end point: 7 days - 1 month - 3 months | — |
Countries
Spain
Contacts
Public ContactSERVICIO DE ANESTESIOLOGIA
HOSPITAL UNIVERSITARI DE BELLVITGE
Outcome results
None listed