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Shifting Pain Modulation From Pro-to Anti-nociceptive

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ClinicalTrials.gov Identifier: NCT02672202
Recruitment Status : Terminated (Recruitment rate was slow so we could not complete the study.)
First Posted : February 3, 2016
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
To create a data base that will facilitate the enrichment of the insights regarding post-operative pain development, and to identify those individuals with the potential to develop this kind of pain. The identification will be based on the individualized pain modulation profile, composed of a battery of tests as detailed below.

Condition or disease Intervention/treatment Phase
Post-operative Chronic Pain Drug: Duloxetine Drug: Pregabalin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Shifting Pain Modulation From Pro-to Anti-nociceptive: Individualized Prevention of Post Operative Pain
Study Start Date : February 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Duloxetine
Treatment
Drug: Duloxetine
  • 60 mg/d - twice before surgery and once a day for post operative days 3-7
  • 30 mg/d - once a day for post operative days 1-2

Drug: Placebo
  • non-active - twice before surgery
  • non-active - twice a day for post operative days 1-7

Active Comparator: Pregabalin
Treatment
Drug: Pregabalin
  • 75 mg/d - twice a day for post operative days 1-2
  • 150 mg/d - twice a day for post operative days 3-7 300 mg/d - twice before surgery

Placebo Comparator: Placebo Drug: Placebo
  • non-active - twice before surgery
  • non-active - twice a day for post operative days 1-7




Primary Outcome Measures :
  1. Change in pain scores as measured by numerical pain scale (NPS) [ Time Frame: 6 months ]
    Change in post-operative pain - acute post operative pain transform into chronic pain. A periodic phone call will be pursued at 1, 2, 4 weeks and 6 months after surgery

  2. Therapeutic response to the analgesic drugs [ Time Frame: 48 hours ]
    The level of the pain relief. Acute post-operative pain measured by analgesic consumption during hospitalization.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American society of anesthesiologists (ASA) I - III patients planned for elective herniorraphy.

Exclusion Criteria:

  • Report of pain at hernia site for more than 30 on 0-100 Numeric Pain Scale (NPS) (ranging from 0, denoting ''no pain'', to 100, denoting ''the worst pain imaginable''), for most of the days during past one month.
  • Regular use of analgesia for any purpose, including serotonin-norepinephrine re-uptake inhibitors (SNRIs) and gabapentins during the previous month.
  • Use of monoamine oxidase inhibitors (MAOIs) within the last 14 days.
  • Narrow-angle glaucoma.
  • Known pregnancy or lactation.
  • Chronic pain disorders.
  • Inability to perform psycho-physical testing, as in the case of cognitive or psychiatric disorders. Participants will sign a consent form before recruitment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672202


Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: David Yarnitsky Head of Neurology department at Rambam
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02672202    
Other Study ID Numbers: 614-15-RMB Hernia_CTIL
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Keywords provided by Rambam Health Care Campus:
Chronic Pain
Pain Modulation Profile
CPM
acute post operative pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Pregabalin
Duloxetine Hydrochloride
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents