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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores improved methods for managing pain after jaw surgery. It compares two groups: one follows a standard opioid prescription plan, while the other uses a personalized plan that gradually reduces medication. The researchers aim to determine if personalized plans result in less leftover medication and better pain management. Individuals who have undergone jaw surgery to correct facial and jaw issues and are not currently on opioids may be suitable candidates. The results could enhance pain management and reduce opioid misuse in the future. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand its benefits for a broader range of patients.

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

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic opioids, you would not be eligible to participate.

What is the safety track record for hydromorphone in this trial?

Research has shown that hydromorphone, the treatment used in this study, is generally safe for managing post-surgical pain. Several studies have examined its safety and efficacy for pain relief. One study found that hydromorphone use did not increase the need for additional pain medication after surgery. Another study demonstrated that it provided early pain relief and improved sleep and mood for patients undergoing bone or joint surgery. These findings suggest that hydromorphone is well-tolerated for managing post-surgical pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a personalized approach to prescribing hydromorphone for postoperative pain. Unlike the standard of care, which provides a fixed dose without tapering instructions, the personalized method tailors the hydromorphone dose based on each patient's in-hospital use, and includes a tapering plan. This approach aims to optimize pain management while minimizing the risk of opioid dependency, offering a potentially safer and more effective strategy for managing postoperative pain.

What evidence suggests that this trial's treatments could be effective for managing postoperative pain after orthognathic surgery?

Research has shown that hydromorphone effectively manages moderate to severe pain. It works well for both sudden pain, such as post-surgical pain, and long-term pain. As a strong painkiller, hydromorphone often helps when other medications fall short. In this trial, participants in the Personalized Prescription Group (POP) will receive a tailored hydromorphone prescription, with doses adjusted to individual needs. This can lead to better pain management, higher satisfaction, and less leftover medication. This personalized approach is crucial for addressing issues related to opioid misuse. ^{6 7 8 9 10}

Who Is on the Research Team?

Jean-Charles Doucet, DMD, MD, MSc

Principal Investigator

Dalhousie University

Amr Alsabbagh, DDS

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0885392402006437

A Systematic Review of Hydromorphone in Acute and ... The aim of this review was to assess the efficacy and tolerability of the opioid analgesic, hydromorphone, for the management of both chronic and acute pain.

2. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... The systematic review addressed the effectiveness of long-term opioid therapy for outcomes related to pain, function, and quality of life ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470393/

Hydromorphone - StatPearls - NCBI Bookshelf - NIH Hydromorphone is a potent opioid medication for managing moderate-to-severe acute and severe chronic pain in patients.

4. mdanderson.org mdanderson.org/documents/for-physicians/algorithms/clinical-management/clin-management-post-op-pain-web-algorithm.pdf

Peri-Operative Pain Management Codeine, morphine, hydromorphone, and oxycodone should be used with caution in patients with decreased renal function. ○ Opioids NOT recommended for cancer ...

5. mbc.ca.gov mbc.ca.gov/Download/Publications/pain-guidelines.pdf

Guidelines for Prescribing Controlled Substances for Pain Use of a pain management agreement is strongly recommended for patients when the opioid therapy is expected to require more than three months of opioids or when ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223001277

Intraoperative hydromorphone decreases postoperative pain This study found that hydromorphone, an intermediate-acting opioid, did not lead to increased pain or opioid requirements postoperatively.

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1567328/full

Efficacy and safety of hydromorphone for postoperative ... Hydromorphone-based PCIA enhances early postoperative pain relief in orthopedic surgery patients, alleviates postoperative depression and sleep disturbances.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3747287/

Postoperative Pain Control - PMC - PubMed Central - NIH A recent observational study showed that single-dose intrathecal opioid followed by IV PCA resulted in better pain control than CEA in patients undergoing ...

9. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2016/09002/abstract_pr231__efficacy_and_safety_of.224.aspx

Abstract PR231: Efficacy and Safety of Hydromorphone for. ... The aim of this study was to evaluate the efficacy and safety of morphine and hydromorphone intravenous injection for postoperative analgesia in children.

10. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01412-8

Effectiveness of analgesia with hydromorphone hydrochloride ... Hydromorphone hydrochloride is a more effective analgesic than sufentanil for postoperative pain in pediatric patients following surgical repair ...