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Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use

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ClinicalTrials.gov Identifier: NCT03248765
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.)
First Posted : August 14, 2017
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this study is to determine if the research results obtained in animal models of pain - that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain - also apply to patients with chronic pain.

Condition or disease Intervention/treatment
Pain, Chronic Opioid Use Other: post-surgical opioid use measured at 1 day and 1 week.

Detailed Description:

The prevalence of chronic pain is very high in the US at approximately 30%. More than 10% of adults report having daily pain. Opioid pain medications [such as morphine] are prescribed for some pain conditions and, since they are very addictive, they can be used inappropriately and abused, to the point of causing overdose and death. This is currently a significant problem in the US and worldwide. Research on changes in the brain that cause addiction in pain patients is complicated, also because it is difficult to separate the effect of the drugs that cause addiction from the direct effect of pain on the brain. Studies in animals have found that pain per se can change the brain in ways that increase the risk of becoming addicted to pain medications. Therefore, we think that patients who have chronic pain and are prescribed opioid pain medications to treat surgery-related pain after surgery, although they never took opioids for a long time in their life, may be at increased risk of using too much opioid medications, and using opioids for a longer time than expected to treat their surgical pain.

The purpose of this study is to determine if the research results obtained in animal models of pain (that show that being in pain for some time increases opioid use beyond what is expected to treat the current pain) also apply to patients with chronic pain.

For our study we are looking to recruit patients scheduled for abdominal surgery at Barnes Jewish Hospital. If eligible and enrolled, subjects will undergo sensory testing (a test of the sensitivity of the skin to hot and cold temperature and pressure) and complete questionnaires about their experience with pain, anxiety, depression and risk of substance abuse. They will also have a one-time blood draw for genetic testing, to look for a particular gene that is potentially associated with how we respond to pain medications and, potentially, with increased risk for addiction. After the surgery, patients will be assessed by the research team on day 1, week 1, week 4, week 8, and after 6 months with similar questionnaires to those that were completed pre-surgery. Patient satisfaction with their pre-surgical and post-surgical pain control will also be assessed by questionnaire.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Chronic pain group
post-surgical opioid use measured at 1 day and 1 week.
Other: post-surgical opioid use measured at 1 day and 1 week.

Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1).

2) Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit ).


No chronic pain
post-surgical opioid use measured at 1 day and 1 week.
Other: post-surgical opioid use measured at 1 day and 1 week.

Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1).

2) Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit ).





Primary Outcome Measures :
  1. Post-surgical opioid use [ Time Frame: 24 hours post-operatively ]
    oral morphine equivalents (mg/day)

  2. Post-surgical opioid use [ Time Frame: 1 week post-operatively ]
    oral morphine equivalents (mg/day)


Biospecimen Retention:   Samples With DNA
Genotype analysis will be performed to control for A118G single nucleotide polymorphism (SNP).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with and without chronic musculoskeletal pain or osteoarthritis pain that are having planned non-cancer related surgery
Criteria

Inclusion Criteria:

  1. Age 18-65
  2. With and without history of chronic muscle-skeletal pain *
  3. Scheduled to undergo elective abdominal surgery requiring overnight hospital admission
  4. Opioid naïve**
  5. Willing to comply with study procedures as outlined in the protocol
  6. Willing and able to provide informed consent
  7. Having an email address and access to a computer or electronic tablet

Exclusion Criteria:

  1. Current use of opioids (includes ANY use in past 3 months)
  2. Cancer diagnosis
  3. Patient presenting the following documented conditions:

Untreated psychosis Current suicidal ideation Current substance abuse


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): NCT03248765


Locations
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United States, Missouri
Washington University in St Louis School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Laura Cavallone, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03248765    
Other Study ID Numbers: 201707017
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents