Standardized Prescription for Post-Surgical Pain Management

Overseen By Anuj Bhatia, MD FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Opioids

Disqualifiers: Cognitive impairment, Language barrier, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

292 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine if a standardized evidence-based opioid prescription following elective hand and forearm surgery at Toronto Western Hospital (TWH) will decrease the number of unused opioid pills consumed by patients while still maintaining adequate pain control as compared to usual treatment. Currently, no standardized prescription exists at our institution.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but if you are on chronic opioid treatment (more than 6 tablets of Oxycodone 5 mg per day or equivalent), you cannot participate.

What data supports the effectiveness of the drug Standardized Prescription for Post-Surgical Pain Management?

Research shows that oral oxycodone, a component of the treatment, is effective for acute postoperative pain relief. Additionally, a study found that combining oxycodone with acetaminophen and ketorolac provided better pain control and fewer complications after hand and wrist surgery. ^{1 2 3 4 5}

Is the standardized prescription for post-surgical pain management using oxycodone safe for humans?

Research shows that oxycodone, when combined with acetaminophen, can be effective for pain relief with fewer side effects compared to using oxycodone alone. However, oxycodone use has been linked to adverse events and potential for abuse, so it should be used carefully under medical supervision. ^{1 6 7 8 9}

How is the drug Oxycodone used in post-surgical pain management different from other treatments?

Oxycodone is an opioid that provides effective relief for acute postoperative pain, and it is often used in combination with other medications like acetaminophen and ketorolac to enhance pain control and reduce complications. This standardized prescription approach aims to optimize pain management while minimizing opioid use and potential dependence. ^{1 2 3 5 10}

Research Team

Anuj Bhatia, MD FRCPC

Principal Investigator

UHN

Eligibility Criteria

This trial is for patients at Toronto Western Hospital having elective hand and forearm surgery who can take 'as needed' pain medication. It's not for those with cognitive issues, language barriers preventing diary completion, refusal to participate, or currently on chronic opioid treatment of more than 6 Oxycodone 5 mg tablets daily.

Inclusion Criteria

Patients presenting to TWH for elective ambulatory hand and forearm surgery

Exclusion Criteria

You cannot complete a patient diary because of a language barrier.

You have a condition that affects your ability to take pain medication as needed.

Chronic opioid treatment, defined as more than 6 tablets of Oxycodone 5 mg per day (or equivalent)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Participants are assessed for current opioid use and risk for narcotic abuse using the opioid risk tool (ORT), and fill out questionnaires on neuropathic pain, anxiety, depression, and catastrophizing.

1 day

1 visit (in-person)

Treatment

Participants undergo elective ambulatory hand and forearm surgery and receive either a standardized or usual discharge opioid prescription.

1 day

1 visit (in-person)

Follow-up

Participants are monitored post-discharge at weeks 1, 6, and 12 to assess pain and opioid use.

12 weeks

3 visits (telephone)

Treatment Details

Interventions

• Standardized Prescription

Trial Overview The study tests if a standardized prescription for opioids after outpatient arm surgery reduces unused pills while managing pain effectively compared to the usual care where no standard exists.

Participant Groups

Group I: Standardized Discharge Prescription Active Control 1 Intervention

Based on a previous study examining mean number of opioid pills used by patients undergoing elective, unilateral hand and forearm surgery

Group II: Usual Discharge Prescription Active Control 1 Intervention

Routine standard of care involves prescription for opioids at the discretion of the surgical team

Standardized Prescription is already approved in United States, European Union, Canada for the following indications:

Approved in United States as OxyContin for:

• Pain management
• Chronic pain
• Acute pain

Approved in European Union as Oxycodone for:

• Severe pain
• Cancer pain
• Neuropathic pain

Approved in Canada as OxyContin for:

• Chronic pain
• Severe pain

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 79 patients undergoing thumb carpometacarpal arthroplasty or distal radius ORIF, the combination of oxycodone, acetaminophen, and ketorolac showed a trend towards better postoperative pain control and reduced opioid usage compared to other regimens.

Although not statistically significant, the group receiving oxycodone, acetaminophen, and ketorolac experienced fewer complications, suggesting that this combination may enhance safety and efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Modal Pain Control in Ambulatory Hand Surgery. Harrison, RK., DiMeo, T., Klinefelter, RD., et al.[2018]

Oral oxycodone is effective for managing acute postoperative pain, showing superior analgesic efficacy compared to placebo and comparable or better pain relief than intravenous opioids in various surgical procedures, including knee arthroplasty and laparoscopic surgeries.

Patients using oral oxycodone experienced fewer side effects than those on other opioids, did not have prolonged hospital stays, and had lower overall drug costs, making it a safe and reasonable alternative for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. Cheung, CW., Ching Wong, SS., Qiu, Q., et al.[2018]

A study of over 1.3 million patients from 1994 to 2014 revealed a significant increase in postoperative opioid prescriptions, with a 145% rise in mean morphine milligram equivalents (MME) for lumbar surgeries and similar increases for knee and hip surgeries.

Patients receiving long-acting opioid formulations, like OxyContin, were 32 times more likely to fill high-dose prescriptions (≥350 MME), indicating a strong link between the introduction of these medications and increased opioid use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Trends in Postoperative Opioid Prescribing, 1994 to 2014. Chen, CL., Jeffery, MM., Krebs, EE., et al.[2021]

The implementation of a postoperative opioid prescription protocol in an otolaryngology department led to a significant reduction in opioid prescriptions for pediatric patients, with 99% not receiving any opioids post-surgery.

For adults, while there was no significant decrease in opioid prescriptions, the protocol did not result in increased unplanned contact or the need for refills, indicating effective pain management without overprescription.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Impact: Implementing an Opioid Prescription Protocol in Otolaryngology. Thal, AG., Ahmed, S., Kim, S., et al.[2023]

In a study of 3,152 patients undergoing various otolaryngology surgeries, 95.7% received opioid prescriptions, but many did not use them as intended, with 58.4% taking half or less of their prescribed supply.

The findings suggest that current opioid prescribing practices do not align with actual patient needs, indicating a need for tailored postoperative pain management strategies that consider the specific analgesic requirements of different surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Use After Elective Otolaryngologic Surgery at a Teaching Institution. Jawad, BA., Lam, KK., Cecola, CF., et al.[2022]

A study involving 68 patients with chronic pain found that the new once-daily oxycodone (OOD) is as effective as the established twice-daily oxycodone (OTD) in managing pain, with no significant difference in analgesic potency.

Both treatments had similar safety profiles, with comparable rates of treatment-related adverse events, suggesting that OOD is a viable alternative to OTD for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the first oxycodone once daily prolonged release tablet in moderate to severe chronic pain: a randomized, double-blind, multicenter, cross-over, non-inferiority study to investigate efficacy and safety in comparison with an established oxycodone twice daily prolonged release tablet. Lux, EA., Janecki, M., Maritz, MA.[2022]

In a study of 10,791 individuals who started oxycodone for non-cancer pain, a significant portion (26% in community settings and 13% in residential aged-care facilities) had not been prescribed any other analgesics in the 12 months prior to starting oxycodone.

The findings suggest that oxycodone is often prescribed without prior trials of other pain medications, raising concerns about potential adverse drug events and overdose risks, especially in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What analgesics do older people use prior to initiating oxycodone for non-cancer pain? A retrospective database study. Gadzhanova, S., Bell, JS., Roughead, EE.[2021]

The reformulated extended-release oxycodone (ERO) showed significantly lower rates of abuse (33% prevalence) compared to the original ERO and immediate-release oxycodone (IR oxycodone), indicating its effectiveness in reducing misuse among individuals with a history of opioid abuse.

After the reformulation, the prevalence of original ERO abuse declined significantly, and there was no evidence that the reformulated ERO became a substitute for the original, suggesting that the new formulation successfully deterred abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. Havens, JR., Leukefeld, CG., DeVeaugh-Geiss, AM., et al.[2014]

The new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) was found to be more effective than a higher dose of oxycodone alone in managing acute pain after oral surgery, based on a study of 141 patients.

This combination not only provided faster pain relief but also resulted in fewer treatment-related side effects, highlighting its potential as a safer alternative for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. Gammaitoni, AR., Galer, BS., Bulloch, S., et al.[2019]

A survey of otolaryngologists revealed that hydrocodone-acetaminophen was the most commonly prescribed opioid for adults after surgery, while acetaminophen was preferred for children, indicating a trend towards cautious opioid use in pediatric patients.

There was significant variation in the number of opioid doses prescribed for different procedures, with tonsillectomy resulting in the highest average of 37 tablets, highlighting the need for standardized prescribing practices to address the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Prescribing Patterns among Otolaryngologists. Schwartz, MA., Naples, JG., Kuo, CL., et al.[2022]

References

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

Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]

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

Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. [2018]

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

Long-Term Trends in Postoperative Opioid Prescribing, 1994 to 2014. [2021]

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

Assessing Impact: Implementing an Opioid Prescription Protocol in Otolaryngology. [2023]

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

Opioid Use After Elective Otolaryngologic Surgery at a Teaching Institution. [2022]

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

Clinical evaluation of the first oxycodone once daily prolonged release tablet in moderate to severe chronic pain: a randomized, double-blind, multicenter, cross-over, non-inferiority study to investigate efficacy and safety in comparison with an established oxycodone twice daily prolonged release tablet. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

What analgesics do older people use prior to initiating oxycodone for non-cancer pain? A retrospective database study. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Opioid Prescribing Patterns among Otolaryngologists. [2022]