Opioid Taper Before Surgery for Arthritis

Overseen By Shakristal Williams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Opioids

Must not be taking: Buprenorphine, Methadone, Long-acting opioids

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a pharmacist-led plan to help individuals reduce opioid use before knee or hip replacement surgery. The researchers aim to determine if this approach is feasible and effective in lowering opioid doses pre-surgery. Participants will collaborate with a pharmacist to gradually reduce their opioid intake by about half over 4-6 weeks. Eligible participants have surgery scheduled in the next 4-8 weeks, take stable doses of specific opioids, and can be reached by phone. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance pre-surgery care for future patients.

Will I have to stop taking my current medications?

If you are taking certain types of opioids, like buprenorphine, methadone, or long-acting and transdermal opioids, you cannot participate in the trial. If you are on other opioids, you will need to follow a tapering plan to reduce your dose before surgery.

What prior data suggests that this opioid taper intervention is safe?

Research shows that pharmacist-led programs to reduce opioid use, like the one under study, are generally safe for participants. In one program, personalized care helped patients lower their opioid use safely without increasing the workload for their primary care doctors. Another study found that over 85% of participants successfully reduced their opioid use. Importantly, these studies did not identify any major safety issues or serious side effects. This suggests that reducing opioid use is usually well-tolerated by patients. However, as with any treatment, individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this approach because it focuses on reducing opioid use before surgery through a pharmacist-led intervention. Unlike the standard use of opioids for managing arthritis pain, this method involves a structured tapering plan designed to cut opioid doses by about 50% in the weeks leading up to surgery. This approach not only aims to manage pain effectively but also reduces dependency on opioids, potentially leading to fewer side effects and a smoother recovery post-surgery. The personalized support from a clinical pharmacist and regular follow-ups set this method apart, offering a more tailored and supportive experience for patients.

What evidence suggests that this opioid taper intervention is effective for reducing opioid use before surgery?

Research has shown that reducing opioid use before surgery can be beneficial. In this trial, participants will engage in a pharmacist-led opioid taper intervention, aiming to cut their opioid dose by about 50% during the 4-6 week preoperative period. One study found that patients who reduced their opioid dose by at least half before hip or knee replacement surgery managed their pain better and required fewer opioids afterward. Another study demonstrated that a pharmacist-led program helped patients decrease opioid use and eased the burden on their primary care doctors. Although some studies mention a small risk of harm during tapering, the benefits of reducing opioid use generally outweigh these risks. ^{1 2 3 6 7}

Who Is on the Research Team?

Kevin R Riggs, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people planning to have knee or hip replacement surgery in the next 4-8 weeks, who are currently on a stable opioid dose of 20-90 MME for at least three months. Participants must speak English and have a reliable phone number. Those using certain opioids like Buprenorphine or Methadone, long-acting or transdermal opioids cannot join.

Inclusion Criteria

I have a working phone number.

I have been on a stable dose of 20-90 MME oral opioids for 3 months.

Speaks English

Exclusion Criteria

I am currently taking opioid medication that includes Buprenorphine.

I am currently taking opioid medications, including Methadone.

I am on long-acting opioid painkillers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Opioid Taper

Participants meet with a clinical pharmacist to receive education on pain and opioids and follow an opioid taper schedule. The pharmacist follows up weekly by phone to assess progress and adjust the taper as necessary.

4-6 weeks

Weekly phone follow-ups

Follow-up

Participants are monitored for safety and effectiveness after surgery, including qualitative feedback and satisfaction ratings.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Opioid Taper Intervention

Trial Overview

The study is testing a pharmacist-led program to reduce opioid use before knee or hip surgery. It involves education about pain and opioids, creating an individual tapering plan, and weekly follow-ups by phone to adjust the plan as needed.

How Is the Trial Designed?

Group I: Pharmacist-led opioid taper intervention Experimental Treatment 1 Intervention

The participant will attempt to taper their opioid dose by \~50% during the 4-6 week preoperative period. Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

The individualized discharge opioid prescribing and tapering protocol significantly reduced the total opioid dose prescribed (from a median of 900 MME to 300 MME) for 6 weeks after elective primary spine surgery, indicating its efficacy in managing postoperative pain while minimizing opioid use.

The protocol, initially designed for joint replacement patients, was successfully adapted for spine surgery patients, demonstrating its potential for broader application across different surgical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a patient-specific tapering protocol at discharge decreases total opioid dose prescribed for 6 weeks after elective primary spine surgery. Joo, SS., Hunter, OO., Tamboli, M., et al.[2021]

A retrospective study showed that implementing data-based opioid risk reviews can potentially reduce serious adverse events (SAEs) related to opioid use, including overdoses and suicide-related events, in the 6 months following the review.

However, the study also found that tapering or discontinuing opioid therapy significantly increased the risk of suicide-related events and opioid-related SAEs, indicating that careful management is crucial during these processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. Pogue, J., Lau, L., Boyer, J.[2023]

In a study of 110 patients undergoing spine surgery, those who followed an individualized opioid tapering plan were more successful in reducing their opioid use to zero after one year compared to those receiving standard care (81% vs. 61%).

The individualized tapering plan, which included telephone counseling one week post-discharge, also resulted in fewer patients unable to taper back to their preoperative opioid dose (2% in the intervention group vs. 14% in the control group).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individualised tapering protocol reduces opioid use 1 year after spine surgery: A randomised controlled trial of patients with preoperative opioid use. Uhrbrand, PG., Rasmussen, MM., Haroutounian, S., et al.[2023]

A new patient-specific discharge protocol for prescribing and tapering opioids after total hip arthroplasty (THA) led to a significant 63% reduction in the total opioid dosage prescribed over six weeks, from a median of 900 MME to 295 MME.

The initial discharge prescription also decreased significantly from a median of 675 MME to 180 MME, indicating that the protocol effectively reduced opioid use without increasing the need for refills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Patient-Specific Opioid Prescribing and Tapering Protocol Is Associated with a Decrease in Total Opioid Dose Prescribed for Six Weeks After Total Hip Arthroplasty. Tamboli, M., Mariano, ER., Gustafson, KE., et al.[2021]

In a study involving 25 patients, most reported a positive experience with a pharmacist-led opioid tapering program, highlighting its patient-centered approach and access to knowledgeable pharmacists, which contributed to improved quality of life.

After completing the tapering program, 72% of patients felt their pain was reduced or manageable, indicating that the program was effective in helping them reduce opioid use while maintaining pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I really had somebody in my corner." Patient experiences with a pharmacist-led opioid tapering program. Schneider, JL., Firemark, AJ., Papajorgji-Taylor, D., et al.[2023]

In a study of 341 surgical patients with chronic opioid use, 13% successfully tapered off opioids completely within 60 days post-surgery, leading to significant improvements in self-reported pain intensity and pain interference.

Patients who achieved complete tapering were more likely to have lower baseline opioid use and longer hospital stays, indicating that careful management during recovery can enhance outcomes for those looking to reduce opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete opioid cessation after surgery improves patient-reported pain measures among chronic opioid users. Holeman, TA., Buys, MJ., Bayless, K., et al.[2022]

A personalized opioid tapering plan significantly improved the ability of patients with preoperative opioid use to reduce their opioid consumption after spine surgery, with only 9% unable to taper to preoperative levels compared to 25% in the standard care group.

Patients following the personalized tapering plan also had fewer pain-related healthcare contacts in the first two weeks after discharge, indicating better management of their postoperative pain without increasing opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making approach to taper postoperative opioids in spine surgery patients with preoperative opioid use: a randomized controlled trial. Uhrbrand, P., Rasmussen, MM., Haroutounian, S., et al.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589537020303400

Efficacy of motivational-interviewing and guided opioid ...

Patients receiving MI-Opioid Taper had a 62% increase in the rate of return to baseline opioid use after surgery (HR 1.62; 95%CI 1.06–2.46; p = 0•03). No trial- ...

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associationofanaesthetists-publications.onlinelibrary.wiley.com

associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/am-pdf/10.1111/anae.16390

A pilot multicentre randomised clinical trial to determine the ...

In a retrospective study, patients who underwent THA or TKA and tapered their pre-operative opioid dose by at least 50% pre-operatively were matched with ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7213382/

A Pharmacist-Led Program to Taper Opioid Use at Kaiser ...

The STORM program provides individualized care to assist patients with opioid tapering while reducing the burden on PCPs.

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2795159

Comparative Effectiveness of Opioid Tapering or Abrupt ...

This study identified a small absolute increase in risk of harms associated with opioid tapering compared with a stable opioid dosage.

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cdc.gov

cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ...

The systematic review addressed the effectiveness of long-term opioid therapy for outcomes related to pain, function, and quality of life ...

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researchprotocols.org

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Efficacy and Safety of a Digital Tapering Intervention for ...

With regard to the secondary outcomes, we estimate that more than 85% of the participants in intervention group will be able to taper completely ...

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rapm.bmj.com

rapm.bmj.com/content/49/10/699

Opioid tapering after surgery and its association with patient ...

Partial and complete opioid tapering within 90 days after surgery among patients with chronic opioid use was associated with improved patient-reported measures ...