Shifting Pain Modulation From Pro-to Anti-nociceptive: Individualized Prevention of Post Operative Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 9
- Primary Endpoint
- Therapeutic response to the analgesic drugs
Study Overview
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.
Detailed Description
Background
Pro-nociceptive pain modulation profile (PMP) is characterized by either:
(i) decreased inhibition of pain, i.e.inhibitory pro-nociceptive PMP, (ii) increased facilitation, i.e. facilitatory pro-nociceptive PMP, or (iii) both, i.e. dual pro-nociceptive PMP.
The counterpart of pro-nociceptive, i.e., anti-nociceptive PMP, has not yet been explored. The investigators expect individuals harboring this profile to be at lower risk for pain acquisition, and experience less intense pain. Pain modulation is commonly altered in pain patients toward a pro-nociceptive pain modulation profile (PMP), expressed, in the lab, by increased facilitation and/or decreased inhibition of experimental pain, and clinically by high pain phenotype.
The proposed study seeks to explore the yet to be characterized mirror image of pro-nociception, i.e., the situation where individuals exhibit reduced pain facilitation and more efficient pain inhibition. This domain of 'anti-nociceptive' PMP is a potential platform for improving pain therapy and prevention. Extrapolating from the clinical picture of pro-nociception, it is likely that 'antinociceptive' individuals will express a lower pain phenotype, with less frequent and less intense pain experiences, lower risk of acquiring pain after surgery or trauma, and, possibly, better response to analgesics. The investigators would like to explore whether it is possible to shift pain modulation towards anti-nociception, in order to obtain the possible benefits of this modulation profile in pain-prone situations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Duloxetine
Treatment
Intervention: Duloxetine (Drug)
Duloxetine
Treatment
Intervention: Placebo (Drug)
Pregabalin
Treatment
Intervention: Pregabalin (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
No secondary outcomes reported