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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are: * Is the intervention feasible and acceptable to patients? * Does the intervention result in a decrease in opioid dose during the 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.

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 data supports the effectiveness of the treatment Opioid Taper Intervention, Preoperative Opioid Taper, Pharmacist-Led Opioid Taper for arthritis surgery?

Research shows that personalized opioid tapering plans, especially when combined with pharmacist support, help patients reduce opioid use after surgery. In studies involving spine surgery patients, those with individualized tapering plans were more successful in reducing or stopping opioid use compared to standard care. ^{1 2 3 4 5}

Is opioid tapering before surgery safe for humans?

Opioid tapering, which means gradually reducing opioid use, has been studied in different settings and is generally considered safe, but it can be challenging. Some studies show that tapering can reduce the risk of long-term opioid use and related problems, but it may also increase the risk of serious events like withdrawal symptoms and, in rare cases, suicide-related events. It's important to have medical support during the process. ^{1 2 3 4 6}

How is the Opioid Taper Intervention treatment different from other treatments for arthritis surgery?

The Opioid Taper Intervention is unique because it involves a personalized plan to gradually reduce opioid use before surgery, led by a pharmacist, which is not a standard approach for arthritis surgery. This method aims to minimize opioid dependency and improve pain management outcomes post-surgery. ^{1 2 3 5 7}

Research Team

Kevin R Riggs, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Complete opioid cessation after surgery improves patient-reported pain measures among chronic opioid users. [2022]

2. England 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. [2023]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

"I really had somebody in my corner." Patient experiences with a pharmacist-led opioid tapering program. [2023]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. [2023]

7. England 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. [2021]