Study to Compare Pain Protocol With and Without Opioids Following Total Joint Arthroplasty

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 18-004256
    NCT ID: NCT03845881
    Sponsor Protocol Number: 18-004256

About this study

The purpose of this study is to compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the non-opioid treatment group.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 and ≤ 90 years.
  • Willing to participate in the study.
  • Competent to provide informed consent.
  • Willing to comply with protocol procedures.
  • Has an underlying diagnosis of osteoarthritis indicated for a total hip or knee arthroplasty.

Exclusion Criteria:

  • A diagnosis of renal or liver disease.
  • If a patient has a contraindication to receiving a spinal anesthetic or pain catheter.
  • The patient must not have taken any narcotic medications during the 3 months leading up to the surgery.
  • The patient must not be allergic or intolerant to a medication used in the multi-modal pain pathway.
  • Revision knee arthroplasty.
  • If a patient is being treated under worker’s compensation.
  • Uncontrolled diabetes with A1C > 8.0 %
  • Unable to take Aspirin 81 (325 mg) twice daily for deep venous thromboprophylaxis.
  • Patients with planned discharged to a skilled nursing facility.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Benjamin Wilke, M.D.

Open for enrollment

Contact information:

Lori Chase CCRP

(904)953-3464

Chase.Lori@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available