Personalization of Opioid Prescription Following Orthognathic Surgery

NCT05708521 | Active Not Recruiting Phase 4

• 1 other identifier: 52007
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Orthognathic Surgery; Opioid Use; Patient Satisfaction; Opioid Use Disorder

Keywords

Personalized Opioid Prescription; Opioid Tapering Protocol; Orthognathic Surgery; Post-Operative Pain; Patient Satisfaction

Outcome Measures

Primary Outcomes (2)

• Fraction (%) of remaining unused opioid

  The participant will self-report how much liquid hydromorphone (1mg/mL) remains in millilitres after they have stopped consuming it for management of their acute post-surgical pain, expected to be at 7-days post-op. The participant will also bring their remaining opioid to their first follow-up appointment to confirm this measurement. The remaining opioid is compared to their prescribed opioid to determine the relative amount of unused opioid measured as a percentage.

  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.

• Absolute amount (milligrams) of remaining unused opioid

  The participant will self-report how much liquid hydromorphone (1mg/mL) remains in millilitres after they have stopped consuming it for management of their acute post-surgical pain, expected to be at 7-days post-op. The participant will also bring their remaining opioid to their first follow-up appointment to confirm this measurement. The remaining opioid is compared to their prescribed opioid to determine the absolute amount of unused opioid measured in milligrams.

  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.

Secondary Outcomes (4)

• Overall satisfaction with post-surgical pain management at home

  Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication.

• Mean duration of usage of opioids

  Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication

• Total daily use of opioid by the participant

  Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication

• Average daily pain scores following discharge

  Assessed at the 7-day post-discharge period, which is the point at which participants would have completed their post-operative recovery period and are expected to have used most of their prescribed opioid medication

Study Arms (2)

Standardized Prescription Group (SOP)

ACTIVE COMPARATOR

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.

Drug: Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery

Personalized Prescription Group (POP)

EXPERIMENTAL

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.

Drug: Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery

Interventions

Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery DRUG

POP participants will be given a personalized opioid prescription with a tapering protocol based on their last inpatient 24-hour usage of opioids, obtained from the nursing medication administration record. Should a participant stay in the hospital for less than 24 hours (e.g. patient had an early discharge at 18 hours), the 24-hour in-patient opioid usage would be extrapolated from their total amount and frequency of opioid use. The participant will be provided with an instruction card with suggestions on how much opioid to take at various time points following discharge to safely taper their medication.

Personalized Prescription Group (POP)

Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery DRUG

SOP participants will be given a standardized dose of hydromorphone (2-4mg orally every 6 hours), and a total amount of 40mg. No further information is provided to them with regards to their pain medication and to tapering.

Standardized Prescription Group (SOP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Patients undergoing an isolated functional genioplasty.
• Patients who are unable to consent to surgery and/or the study.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (20)

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MeSH Terms

Conditions

Pain, Postoperative; Patient Satisfaction; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amr Alsabbagh, DDS

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Jean-Charles Doucet, DMD, MD, MSc

  Dalhousie University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to which group they are assigned to avoid the placebo effect. Given the nature of the study in which opioid prescription quantities are controlled and questionnaires provide a detailed schedule of opioid dosage and frequency, providers and investigators cannot be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Oral and Maxillofacial Surgery, Masters Graduate Student

Model Details: Participants will be randomly allocated to one of 2 parallel study arms and followed longitudinally. Their allocation to the study arms will be performed by using a random number generator, whereby if the number 0 arises, they are allocated to the control group, and if the number 1 arises, they are assigned to the experimental group.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: April 24, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)