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

NCT03248765 | Terminated

• 1 other identifier: 201707017
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Post-surgical opioid use

  oral morphine equivalents (mg/day)

  24 hours post-operatively

• Post-surgical opioid use

  oral morphine equivalents (mg/day)

  1 week post-operatively

Study Arms (2)

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.

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.

Interventions

post-surgical opioid use measured at 1 day and 1 week. OTHER

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 ).

Chronic pain group; No chronic pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with and without chronic musculoskeletal pain or osteoarthritis pain that are having planned non-cancer related surgery

You may qualify if:

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

You may not qualify if:

• Current use of opioids (includes ANY use in past 3 months)
• Cancer diagnosis
• Patient presenting the following documented conditions:
• Untreated psychosis Current suicidal ideation Current substance abuse

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Genotype analysis will be performed to control for A118G single nucleotide polymorphism (SNP).

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Cavallone, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: August 30, 2017
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

US (1)