Personalization of Opioid Prescription Following Orthognathic Surgery (NCT05708521) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Personalization of Opioid Prescription Following Orthognathic Surgery
Canada201 participantsStarted 2023-04-24
Plain-language summary
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 can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients undergoing orthognathic surgery for the correction of dentofacial deformities. Included in the study will be patients who receive single-jaw surgery (i.e. BSSO \[Bilateral Sagittal Split Osteotomy, a surgery of the lower jaw\] only, or Lefort \[osteotomy of the upper jaw\] only), or those in the double-jaw surgery category (BSSO and Lefort).
. Patients undergoing a functional genioplasty who have an additional osteotomy included in their surgical plan (i.e. BSSO and/or Lefort).
. Patients undergoing cleft orthognathic surgery.
Exclusion criteria
. Patients who are under the age of 18 at the time of surgery
. Patients who are contraindicated to undergo elective surgery, including pregnant patients.
. Patients with a history of opioid use disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fraction (%) of remaining unused opioid
Timeframe: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.
2
Absolute amount (milligrams) of remaining unused opioid
Timeframe: Assessed at 7-days post-discharge, which is the point at which participant would have completed their post-operative recovery period and are expected to have ceased using their prescribed opioid medication.
. Patients on chronic opioids within the past month.
. Patients who have a contraindication for multimodal analgesia (e.g. renal injury precluding the prescription of NSAIDs).
. Patients with allergies to opioids, acetaminophen, and/or NSAIDs.
. Patients receiving a surgically-assisted rapid palatal expansion (SARPE) surgery due to the different post-operative nature of the surgery.
. Patients who have previously undergone prior orthognathic (i.e. repeat surgery), non-cleft craniofacial surgery, or have previously experienced maxillofacial trauma due to the potential alterations in neural pain pathways.