Personalized Opioid Prescribing for Postoperative Pain

Overseen By Amr Alsabbagh, DDS

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Nova Scotia Health Authority

Must not be taking: Chronic opioids

Disqualifiers: Under 18, Pregnant, Opioid use disorder, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 3

201 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner. The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders. Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used. The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.

Who Is on the Research Team?

Amr Alsabbagh, DDS

Principal Investigator

Dalhousie University

Jean-Charles Doucet, DMD, MD, MSc

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

This trial is for adults having orthognathic surgery to fix jaw and facial bone problems, including single or double-jaw surgeries, and those with additional osteotomies. It excludes minors, pregnant women, patients with opioid use disorder or recent chronic opioid use, those allergic to pain meds like NSAIDs or acetaminophen, and anyone who can't consent.

Inclusion Criteria

I am having surgery to correct a jaw or facial deformity.

I am having surgery to correct a cleft jaw.

I am having a chin surgery that includes cutting the bone, along with other jaw surgeries.

Exclusion Criteria

I am having surgery to change the shape of my chin.

You are allergic to opioids, acetaminophen, or NSAIDs.

I am undergoing or have undergone SARPE surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-surgery

Data collection from pre-surgery appointments including demographics and medical history

1 week

1 visit (in-person)

Surgery and Hospital Stay

Participants undergo orthognathic surgery and are monitored during their hospital stay

Several days

In-patient stay

Post-discharge Treatment

Participants receive either a standardized or personalized opioid prescription plan for pain management

7 days

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of unused opioids and satisfaction

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hydromorphone

Trial Overview The study compares two post-surgery pain management plans: one standard hydromorphone prescription versus a personalized plan that includes tapering off the drug. The goal is to see which leads to less leftover medication and better patient satisfaction.

How Is the Trial Designed?

Group I: Personalized Prescription Group (POP) Experimental Treatment 1 Intervention

All participants assigned to the POP group will receive pre-operative education on the medications that they will be given while they are inpatients and upon discharge, along with a pain medication card to aid their understanding. Medications upon discharge will be: 1. Acetaminophen 975mg orally every 6 hours for 1 week 2. Ibuprofen 600 mg orally every 6 hours for 1 week 3. Hydromorphone - Prescribed with a personalized schedule and tapering protocol based on the participant's last 24-hour in-patient use of opioids. Participants in this arm will also receive tapering instructions as well as an education card to assist them with their tapering protocol upon discharge.

Group II: Standardized Prescription Group (SOP) Active Control 1 Intervention

All participants assigned to the SOP group will be treated as per the current status quo, in which they are given the standardized analgesic prescriptions following discharge from the hospital consisting of: 1. Acetaminophen 975 mg orally every 6 hours for 7 days 2. Ibuprofen 600 mg orally every 6 hours for 7 days 3. Hydromorphone 2-4 mg orally every 6 hours as needed, with a total dispense amount of 40mg. The participants are not given instructions on how to taper their hydromorphone medication, which is the current status quo in our department.

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

Approved in United States as Dilaudid for:

• Moderate to severe pain

Approved in Canada as Hydromorphone for:

• Moderate to severe pain

Approved in European Union as Hydromorphone for:

• Moderate to severe pain

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+