Personalization of Opioid Prescription Following Orthognathic Surgery

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Treatments: Hydromorphone

Criteria

Inclusion criteria

1. 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).

2. Patients undergoing a functional genioplasty who have an additional osteotomy included in their surgical plan (i.e. BSSO and/or Lefort).

3. Patients undergoing cleft orthognathic surgery.

Exclusion criteria

1. Patients who are under the age of 18 at the time of surgery

2. Patients who are contraindicated to undergo elective surgery, including pregnant patients.

3. Patients with a history of opioid use disorder.

4. Patients on chronic opioids within the past month.

5. Patients who have a contraindication for multimodal analgesia (e.g. renal injury precluding the prescription of NSAIDs).

6. Patients with allergies to opioids, acetaminophen, and/or NSAIDs.

7. Patients receiving a surgically-assisted rapid palatal expansion (SARPE) surgery due to the different post-operative nature of the surgery.

8. 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.

9. Patients undergoing an isolated functional genioplasty.

10. Patients who are unable to consent to surgery and/or the study.