Shifting Pain Modulation From Pro-to Anti-nociceptive

NCT02672202 | Terminated

• 1 other identifier: 614-15-RMB Hernia_CTIL
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-operative Chronic Pain

Keywords

Chronic Pain; Pain Modulation Profile; CPM; acute post operative pain

Outcome Measures

Primary Outcomes (2)

• Change in pain scores as measured by numerical pain scale (NPS)

  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

  6 months

• Therapeutic response to the analgesic drugs

  The level of the pain relief. Acute post-operative pain measured by analgesic consumption during hospitalization.

  48 hours

Study Arms (3)

Duloxetine

ACTIVE COMPARATOR

Treatment

Drug: Duloxetine; Drug: Placebo

Pregabalin

ACTIVE COMPARATOR

Treatment

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Duloxetine DRUG

* 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

Duloxetine

Pregabalin DRUG

* 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

Pregabalin

Placebo DRUG

* non-active - twice before surgery * non-active - twice a day for post operative days 1-7

Duloxetine; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Duloxetine Hydrochloride; Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David Yarnitsky

  Head of Neurology department at Rambam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09