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Improved Opioid-Tapering Instructions for Osteoarthritis

Phase 4

Waitlist Available

Led By Wolfgang Fitz, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 months following surgery (measured at second postoperative appointment).

Awards & highlights

Study Summary

This trial is testing whether a patient-maintained opioid diary, improved patient educational materials, and using a pain management counselor provides benefits in decreasing narcotic consumption, pain levels, nausea, sleep quality, and patient satisfaction.

Eligible Conditions

Osteoarthritis of the Knee
Opioid Addiction
Chronic Knee Pain
Opioid Use Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 months following surgery (measured at second postoperative appointment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 months following surgery (measured at second postoperative appointment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 months following surgery (measured at second postoperative appointment). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid Usage After One Week

Total Opioid Consumption: Amount

Total Opioid Consumption: Days

Secondary outcome measures

Opioid Usage After Two Weeks

Questionnaire Answers

VAS Score 2: "How much pain do you feel in your operative site when moving?"

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Improved Instructions and EducatorExperimental Treatment2 Interventions

Improved opioid-tapering instructions given upon discharge from hospital. Subject receives regular phone calls from educator for counseling in opioid tapering. Subjects record opioid tapering in diary.

Group II: Improved InstructionsExperimental Treatment1 Intervention

Improved opioid-tapering instructions given upon discharge from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary.

Group III: Standard of CareActive Control1 Intervention

Standard instructions from hospital. Subjects talk with hospital staff only when they call the hospital, when RA calls at various benchmarks, and at postoperative clinic visits. Subjects record opioid tapering in diary.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,470,830 Total Patients Enrolled

17 Trials studying Osteoarthritis

29,873 Patients Enrolled for Osteoarthritis

Wolfgang Fitz, MDPrincipal InvestigatorBrigham and Women's Hospital

3 Previous Clinical Trials

181 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the perils associated with Improved Opioid-Tapering Instructions for individuals?

"This phase 4 trial has been approved by the governing body, so we rate its safety as a 3 on our scale."

Answered by AI

Is this research endeavor still recruiting participants?

"The trial information posted on clinicaltrials.gov reveals that this specific medical experiment is no longer recruiting patients, with its first post dating back to June 6th 2022 and the latest edit being done in September 10th 2021. Nevertheless, there are 876 other clinical trials currently accepting participants at present."

Answered by AI

What aims are the researchers hoping to achieve through this clinical trial?

"This trial's primary goal is to measure opioid usage one week after surgery, with secondary objectives including a Visual Analogue Scale (VAS) assessment of surgical site pain and nausea as well as the percentage of patients who have finished taking opioids two weeks post-operation. This will all be observed over roughly 2-3 months or whenever necessary."

Answered by AI

Recent research and studies

The Journal of PainJournal

Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings from a Review of the Evidence for an American Pain Society Clinical Practice Guideline

Gordon, Debra B., Oscar A. de Leon-Casasola, Christopher L. Wu, Kathleen A. Sluka, Timothy J. Brennan, and Roger Chou. 2016. “Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings from a Review of the Evidence for an American Pain Society Clinical Practice Guideline”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2015.10.023.

Pain and TherapyJournal

Alleviating Symptoms of Withdrawal from an Opioid

Wakim, Judith H.. 2012. “Alleviating Symptoms of Withdrawal from an Opioid”. Pain and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40122-012-0004-5.

The American Journal of PathologyJournal

Morphine Decreases Bacterial Phagocytosis by Inhibiting Actin Polymerization Through Camp-, Rac-1-, and P38 Mapk-dependent Mechanisms

Ninković, Jana, and Sabita Roy. 2012. “Morphine Decreases Bacterial Phagocytosis by Inhibiting Actin Polymerization Through Camp-, Rac-1-, and P38 Mapk-dependent Mechanisms”. The American Journal of Pathology. Elsevier BV. doi:10.1016/j.ajpath.2011.11.034.

The Journal of PainJournal