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Opioid Analgesic
Personalized Opioid Prescribing for Postoperative Pain
Phase 4
Recruiting
Led By Amr Alsabbagh, DDS
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing orthognathic surgery for the correction of dentofacial deformities, including single-jaw surgery (BSSO or Lefort) or double-jaw surgery (BSSO and Lefort)
Patients undergoing cleft orthognathic surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial studies pain management and satisfaction after orthognathic surgery to find a safe and effective way to manage the post-operative pain. It will compare two groups with different prescription plans and see which results in less unused opioid medication and higher satisfaction.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Hydromorphone may cause side effects such as nausea, vomiting, constipation, drowsiness, dizziness; in some cases it might lead to dependency issues if not managed properly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery to correct a jaw or facial deformity.
Select...
I am having surgery to correct a cleft jaw.
Select...
I am having a chin surgery that includes cutting the bone, along with other jaw surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute amount (milligrams) of remaining unused opioid
Fraction (%) of remaining unused opioid
Secondary outcome measures
Average daily pain scores following discharge
Mean duration of usage of opioids
Overall satisfaction with post-surgical pain management at home
+1 moreSide effects data
From 2015 Phase 4 trial • 84 Patients • NCT0200972252%
Moderate to Severe Pruritus
40%
Moderate to Severe Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intrathecal Morphine
Intrathecal Hydromorphone
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Prescription Group (POP)Experimental Treatment1 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:
Acetaminophen 975mg orally every 6 hours for 1 week
Ibuprofen 600 mg orally every 6 hours for 1 week
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 Control1 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:
Acetaminophen 975 mg orally every 6 hours for 7 days
Ibuprofen 600 mg orally every 6 hours for 7 days
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.
Find a Location
Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
258 Previous Clinical Trials
83,654 Total Patients Enrolled
Amr Alsabbagh, DDSPrincipal InvestigatorDalhousie University
Jean-Charles Doucet, DMD, MD, MScStudy ChairDalhousie University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery to change the shape of my chin.You are allergic to opioids, acetaminophen, or NSAIDs.I am having surgery to correct a jaw or facial deformity.I am undergoing or have undergone SARPE surgery.I have been using opioids regularly for the past month.I am having surgery to correct a cleft jaw.I am unable to give consent for surgery or this study.I am having a chin surgery that includes cutting the bone, along with other jaw surgeries.I cannot have surgery due to health reasons or because I am pregnant.I have had jaw or facial surgery, or experienced facial trauma before.I am under 18 years old at the time of my surgery.You have a history of being addicted to opioids.I cannot take certain pain medications due to kidney issues.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized Prescription Group (POP)
- Group 2: Standardized Prescription Group (SOP)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any ongoing opportunities for enrollment in this research?
"Clinicaltrials.gov displays that this trial, which was initially listed on March 1st 2023, is not currently searching for participants. Nevertheless 858 other studies are actively enrolling patients at the moment."
Answered by AI
What goals is this trial attempting to achieve?
"The primary outcome of this medical trial is the absolute amount of unused opioid medication at 7 days post-discharge. Secondary outcomes are total daily opioid usage, average daily pain scores after discharge, and the mean duration for which opioids were used following surgery."
Answered by AI
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