Standardized Prescription for Post-Surgical Pain Management
Recruiting in Palo Alto (17 mi)
Overseen byAnuj Bhatia, MD FRCPC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Must not be taking: Opioids
Disqualifiers: Cognitive impairment, Language barrier, others
No Placebo Group
Approved in 3 Jurisdictions
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?
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.16789
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.123510
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)
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Trial 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 (Opioid)
Trial OverviewThe 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
2Treatment groups
Active Control
Group I: Standardized Discharge PrescriptionActive Control1 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 PrescriptionActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto Western HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Multi-Modal Pain Control in Ambulatory Hand Surgery. [2018]We evaluated postoperative pain control and narcotic usage after thumb carpometacarpal (CMC) arthroplasty or open reduction and internal fixation (ORIF) of the distal radius in patients given opiates with or without other non-opiate medication using a specific dosing regimen. A prospective, randomized study of 79 patients undergoing elective CMC arthroplasty or ORIF of the distal radius evaluated postoperative pain in the first 5 postoperative days. Patients were divided into 4 groups: Group 1, oxycodone and acetaminophen PRN; Group 2, oxycodone and acetaminophen with specific dosing; Group 3, oxycodone, acetaminophen, and OxyContin with specific dosing; and Group 4, oxycodone, acetaminophen, and ketorolac with specific dosing. During the first 5 postoperative days, we recorded pain levels according to a numeric pain scale, opioid usage, and complications. Although differences in our data did not reach statistical significance, overall pain scores, opioid usage, and complication rates were less prevalent in the oxycodone, acetaminophen, and ketorolac group. Postoperative pain following ambulatory hand and wrist surgery under regional anesthesia was more effectively controlled with fewer complications using a combination of oxycodone, acetaminophen, and ketorolac with a specific dosing regimen.
Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. [2018]Opioids are the mainstay of pain management for acute postsurgical pain. Oral oxycodone is an opioid that can provide effective acute postoperative pain relief.
Long-Term Trends in Postoperative Opioid Prescribing, 1994 to 2014. [2021]Opioids are routinely prescribed to manage acute postoperative pain, but changes in postoperative opioid prescribing associated with the marketing of long-acting opioids such as OxyContin have not been described in the surgical cohort.
Assessing Impact: Implementing an Opioid Prescription Protocol in Otolaryngology. [2023]A lack of guidance for pain control after otolaryngology surgery can lead to overprescription of opioids. We implemented a postoperative site-specific opioid prescription protocol and analyzed the impact on opioid prescriptions.
Opioid Use After Elective Otolaryngologic Surgery at a Teaching Institution. [2022]Background: Awareness of the opioid epidemic is promoting opioid stewardship in health care. For many commonly performed procedures in general surgery and gynecology, regimented opioid prescribing practices and/or multimodal nonopioid regimens are adequate for optimizing pain management and minimizing opioid dependence. We investigated opioid prescribing patterns for otolaryngology procedures at a tertiary hospital with the aim of characterizing postoperative pain and opioid use. Methods: This cross-sectional study with a patient survey was conducted in a tertiary care academic otolaryngology practice. Patients ≥18 years who underwent 1 of 41 common surgical procedures at an academic hospital between 2013 and 2017 were enrolled. Patients with any diagnosis of malignancy were excluded. Patients were analyzed according to surgery type (rhinoplasty, sinonasal surgery, tonsillectomy, parotidectomy, thyroidectomy, otologic surgery, and laryngoscopy), and those who had surgery in 2017 were surveyed via telephone interview using a standardized questionnaire. Results: A total of 3,152 patients met the study criteria, of whom 95.7% received an opioid prescription. Commonly prescribed opioid agents were hydrocodone-acetaminophen, oxycodone-acetaminophen, and acetaminophen-codeine. A median of 30 pills was prescribed per surgery, with little variation between different surgery types. Reported patient utilization was highest for parotid surgery and tonsillectomy and lowest for laryngoscopic, thyroid, and otologic surgery. Among all patients who received a prescription for opioids, 5.8% required a refill. Among the surveyed patients, 19.6% reported that they did not obtain the prescribed opioid, while 58.4% said they took half, less than half, or none of the prescribed opioid supply. Only 10.8% of surveyed patients disposed of the excess drugs in a recommended fashion. Conclusion: Our findings showed that the quantity of opioid prescriptions does not reflect actual patient analgesic use for elective surgeries in otolaryngology. Differential analgesic requirements for specific surgeries should be considered when prescribing postoperative analgesia.
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]The first oxycodone once daily (OOD) has been developed and after successful pharmacokinetic characterization, therapeutic efficacy and safety were compared to an established oxycodone twice daily (OTD: Oxygesic/OxyContin, Mundipharma).
What analgesics do older people use prior to initiating oxycodone for non-cancer pain? A retrospective database study. [2021]Increased oxycodone use has been associated with adverse drug events, non-medical use and overdose deaths.
The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. [2014]Prescription opioid abuse is a significant public health concern that requires strategies to reduce its impact, including development of abuse deterrent formulations. OxyContin, an extended-release oxycodone (ERO) formulation, has been widely abused. This study assessed the effects of reformulated ERO, designed to be more difficult to manipulate for purposes of intranasal and intravenous abuse, on patterns of opioid abuse among a sample of individuals from rural Appalachia with a history of ERO abuse.
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]This randomized, controlled trial compared the analgesic efficacy and safety of the new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) for the treatment of acute pain following oral surgery with double the dose of oxycodone alone (controlled-release [CR] oxycodone 20 mg [OxyContin]). A total of 150 male and female patients with > or = 2 full or partial bone-impacted mandibular molars, at least moderate persistent pain, and moderate trauma received a single dose of combination agent, CR oxycodone, or placebo following oral surgery and rated pain intensity and pain relief over the next 6 hours. The intent-to-treat population comprised 141 patients (55 on combination agent, 56 on oxycodone, and 30 on placebo). Combination agent and CR oxycodone were significantly superior to placebo for all efficacy measures. Combination agent was statistically superior to CR oxycodone in four of five outcome measures of pain intensity and pain relief (PPID, PPAR, SPID, and SPRID). It also provided a faster onset and 24% reduction in the number of patients reporting treatment-related adverse events compared with twice the dose of opioid alone. This new formulation offers the combination of two analgesic drugs with complementary mechanisms of action, which results in enhanced analgesia, an "opioid-sparing" effect, and an improved side effect and safety profile.
Opioid Prescribing Patterns among Otolaryngologists. [2022]Objectives To evaluate national trends in opioid prescribing patterns by otolaryngologists for postoperative pain control after common otolaryngologic procedures. Study Design Cross-sectional; survey. Subjects and Methods A survey to determine opioid prescribing patterns for the treatment of postoperative pain following common otolaryngologic procedures was distributed to all members of the American Academy of Otolaryngology-Head and Neck Surgery. Results The most common pain medication prescribed for adults postoperatively was hydrocodone-acetaminophen (73%), followed by oxycodone-acetaminophen (39%). The most common pain medication prescribed postoperatively for children was acetaminophen (67%), followed by nonsteroidal anti-inflammatory drugs (65%). Overall, there was a wide variation in quantity of opioids prescribed for each surgery, ranging from 0 to more than 60 doses. Mean opioid prescriptions were greatest for tonsillectomy (37 tablets) and least for direct laryngoscopy (5.3 tablets). Conclusion This study identifies nationwide variations in opioid prescribing patterns among otolaryngologists. While otolaryngology is a relatively small specialty, we still have an obligation to work with all physicians to help combat the current opioid epidemic. By evaluating nationwide postoperative pain regimens, we are moving closer toward understanding how to reduce the opioid burden.