Can Simplified and More Detailed Instructions Affect Post-Operative Narcotic Consumption

NCT03534102 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: OpioidTaperingTKR/THR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to investigate whether (1) a patient-maintained opioid diary provides an accurate measure of opioid consumption (morphine equivalents), (2) improved patient educational materials decrease narcotic consumption, and (3) using a pain management counselor provides additional benefits in decreasing narcotic consumption when used in conjunction with improved educational materials. Furthermore, the investigators would like to investigate the effect of the patient-maintained diaries, the improved educational materials, and the pain management counselor on pain levels, nausea, sleep quality, and patient satisfaction. All patients undergoing orthopedic surgery at Brigham and Women's Faulkner Hospital and choose to participate will be assigned to a treatment group based on which arm of the study is being tested at the time; (the treatment arms are sequential). Members of Group 1 (control group) will receive the current standardized institutional discharge care for orthopedic surgery and an added tracking diary. Members of Group 2 (experimental group 1) will receive more detailed educational materials regarding postoperative pain management - including instructions to how to taper their narcotic usage - as well as a tracking diary. Members of Group 3 (experimental group 2) will receive not only the educational materials of Group 2, but also weekly phone calls from a clinical patient educator to remind them of proper use of the diary and narcotic tapering.

Conditions

Opioid Use; Opioid Dependence; Knee Pain Chronic; Knee Osteoarthritis

Keywords

Total Hip Arthroplasty; Total Knee Arthroplasty; Opioid Dependence; Opioid Tapering

Outcome Measures

Primary Outcomes (3)

• Total Opioid Consumption: Amount

  Total amount of patients' opioid consumption, measured in mg of morphine equivalents.

  2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).

• Opioid Usage After One Week

  The proportion of patients who have finished taking opioids by the first postoperative appointment, approximately one week after surgery.

  7 days following surgery.

• Total Opioid Consumption: Days

  The total number of days in which each patient took opioid medications after surgery.

  2-3 months following surgery, or as needed (total usage assessed after postoperative appointments).

Secondary Outcomes (7)

• Opioid Usage After Two Weeks

  14 days following surgery.

• Visual Analogue Scale (VAS) Score 1: "How much pain do you feel in your operative site when resting?"

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

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

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

• VAS Score 3: "How well are you sleeping?"

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

• VAS Score 4: "How bad is your nausea?"

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

Study Arms (3)

Standard of Care

NO 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.

Improved Instructions

EXPERIMENTAL

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.

Drug: Improved Opioid-Tapering Instructions

Improved Instructions and Educator

EXPERIMENTAL

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.

Drug: Improved Opioid-Tapering Instructions; Behavioral: Clinical Patient Educator

Interventions

Improved Opioid-Tapering Instructions DRUG

Applied to first and second experimental groups in the form of discharge instructions and directions from nursing staff.

Improved Instructions; Improved Instructions and Educator

Clinical Patient Educator BEHAVIORAL

Applied to second experimental group in the form of regular calls about weaning off narcotic medications.

Improved Instructions and Educator

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Date of surgery between 3 weeks and 8 weeks away
• Undergoing total hip or total knee replacement \[including simultaneous bilateral\]
• Eligible based on our standard Faulkner Hospital pre-op assessment

You may not qualify if:

• If female, pregnant
• Undergoing partial joint replacement

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Related Publications (6)

• Gordon DB, de Leon-Casasola OA, Wu CL, Sluka KA, Brennan TJ, Chou R. 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. J Pain. 2016 Feb;17(2):158-66. doi: 10.1016/j.jpain.2015.10.023. Epub 2015 Dec 21.

  PMID: 26719073 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

• Reynolds MA. Postoperative pain management discharge teaching in a rural population. Pain Manag Nurs. 2009 Jun;10(2):76-84. doi: 10.1016/j.pmn.2008.07.003. Epub 2009 Jan 4.

  PMID: 19481046 BACKGROUND

• Wakim JH. Alleviating symptoms of withdrawal from an opioid. Pain Ther. 2012 Dec;1(1):4. doi: 10.1007/s40122-012-0004-5. Epub 2012 Sep 20.

  PMID: 25134933 BACKGROUND

• Ninkovic J, Roy S. Morphine decreases bacterial phagocytosis by inhibiting actin polymerization through cAMP-, Rac-1-, and p38 MAPK-dependent mechanisms. Am J Pathol. 2012 Mar;180(3):1068-1079. doi: 10.1016/j.ajpath.2011.11.034. Epub 2012 Jan 14.

  PMID: 22248582 BACKGROUND

• Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-1265. doi: 10.1097/j.pain.0000000000000516.

  PMID: 26871536 BACKGROUND

Related Links

• Carr DB, Morlion B. Pain After Surgery: What Health-Care Professionals Should Know.

MeSH Terms

Conditions

Opioid-Related Disorders; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wolfgang Fitz, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Orthopedic Surgeon

Model Details: Testing 3 sequential standards of care; each of 3 arms lasts 4 months, and all patients recruited within an arm are assigned to the same treatment.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 23, 2018
• Study Start: June 6, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)