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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a standardized plan for dispensing pain pills after hand and forearm surgery can reduce leftover pills while effectively managing pain. Currently, doctors at the hospital prescribe individually, which might result in more unused pills. The study will compare a new standard prescription using Oxycodone, an opioid pain medication, against the usual doctor-decided prescription. This trial suits patients scheduled for elective hand or forearm surgery who do not regularly take strong pain pills (more than 6 Oxycodone 5 mg tablets daily). As an unphased trial, it offers patients the opportunity to contribute to improving pain management strategies.

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 prior data suggests that this standardized prescription is safe for post-surgical pain management?

Research shows that oxycodone, part of the standard treatment under study, effectively relieves post-surgery pain. Studies have found it works well at doses over 5 mg. However, like many pain medications, oxycodone can cause side effects, such as nausea and other common opioid-related issues.

While this treatment undergoes testing, previous studies provide insight into its safety. Oxycodone is a strong painkiller already used in many situations to manage pain, so doctors are familiar with its effects and possible side effects.

The trial aims to find a balance—reducing leftover opioid pills while still managing pain effectively. For concerns or questions about joining the trial, consulting a healthcare provider could be helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for a Standardized Prescription for Post-Surgical Pain Management because it aims to streamline how pain is managed after surgery, potentially reducing the over-prescription of opioids. Unlike the usual care, where opioid prescriptions are given at the surgical team's discretion, this approach uses a standardized prescription based on past data about actual patient needs. This could lead to a more efficient use of medications, minimizing the risk of opioid dependence while still effectively managing pain. The trial seeks to find out if a one-size-fits-all prescription can safely and effectively meet patients' needs, which could transform post-surgical pain management practices.

What evidence suggests that this standardized prescription is effective for post-surgical pain management?

Research has shown that oxycodone is a strong pain reliever for post-surgical pain. One study found that doses over 5 mg of oxycodone are much more effective than codeine for managing pain after surgeries, such as hand or forearm operations. Oxycodone has been proven to relieve pain better than a placebo, meaning it is more effective than taking nothing. Another study suggested it might provide pain relief similar to fentanyl, another powerful painkiller, but with fewer side effects like headaches. In this trial, participants will receive either a standardized discharge prescription for opioids like oxycodone or the usual discharge prescription, which involves opioids prescribed at the surgical team's discretion. Using a standard prescription can help manage pain effectively and reduce the risk of leftover pills. ^{1 2 3 6 7}

Who Is on the Research Team?

Anuj Bhatia, MD FRCPC

Principal Investigator

UHN

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4170904/

Single dose oral oxycodone and oxycodone plus paracetamol ... Single dose oxycodone is an effective analgesic in acute postoperative pain at doses over 5 mg; oxycodone is two to three times stronger than codeine.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023005357

Tapentadol Versus Oxycodone for Opioid-Related Adverse ... A 2022 study demonstrated that tapentadol IR may be more cost-effective than oxycodone IR for the treatment of acute postoperative pain, on the premise that the ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2786200

Effectiveness of Oxycodone Hydrochloride (Strong Opioid ... This study found that oxycodone did not provide superior pain relief compared with combination acetaminophen and codeine during the first 7 days of treatment.

4. nature.com nature.com/articles/s41598-024-71708-5

Effect of oxycodone versus fentanyl for patient-controlled ... These findings suggest that oxycodone may offer comparable pain relief, higher patient satisfaction, and fewer headaches for patients undergoing laparoscopic ...

5. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NDIxMA%3D%3D&journal=103

Oral Oxycodone for Acute Postoperative Pain Oral oxycodone showed superior postoperative analgesic efficacy compared with placebo in patients undergoing laparoscopic cholecystectomy, abdominal or pelvic ...

6. mayoclinic.org mayoclinic.org/tests-procedures/anesthesia/in-depth/pain-medications/art-20046452

Pain medicines after surgery Opioids are often critical for managing pain after surgery because of their powerful effect. But they can have side effects, including nausea, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03495388

PG and PK of Oxycodone to Personalize Post-op Pain ... The purpose of this research is to study serious immediate and long-term clinical problems from both surgical pain and oxycodone use in children and adolescents ...