Personalization of Opioid Prescription Following Orthognathic Surgery

Pain, Postoperative Clinical Trial

Official title: Optimization of Post-Operative Pain Following Orthognathic Surgery With Personalized Opioid Prescription and Tapering Protocols

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study aims to investigate the use of post-operative pain management following orthognathic surgery, with a focus on the use of opioid medication. Orthognathic surgery is a foundational surgery for the correction of dentofacial deformities, which requires osteotomies, rearrangement, and fixation of the facial bones into a new position. Participants are often placed into maxillomandibular fixation postoperatively, limiting the range of motion of the mandible. The surgical trauma provoked by the osteotomies, stripping of facial muscles, and swelling of the associated soft tissue envelope can result in significant post-operative pain in participants. This pain is one of the primary reasons participants are admitted following surgery for up to several days. Further complicating pain management for these participants is the maxillomandibular fixation, which reduces the ability of participants to verbally communicate with their nursing staff about their levels of pain.

Multimodal analgesia using a combination of acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and opioid medications are the mainstay therapies for acute post-surgical pain. However, long-term opioid use can lead to opioid tolerance, due to various mechanisms, including receptor desensitization and downregulation. This can lead to persistent postoperative opioid use and opioid use disorder.

In Canada, the opioid crisis is on the rise in all provinces, driven by both illegal and prescription opioids. Most opioid-related deaths occurred in males between the ages of 30 to 39, with an overall increase in the use rate amongst younger age groups. Canada has the second highest rate of opioid prescription in the world, after the United States of America. The legitimate use of opioid analgesics in adolescents - who otherwise disapprove of illegal drug use - is independently associated with a 33% increased risk of opioid misuse in later life. Furthermore, persistent opioid use may be the most common complication after elective surgery. Currently, in our department, much like many other oral and maxillofacial surgical centers, there is a "standardized" prescription of opioids, such as hydromorphone, for all participants being discharged from the hospital. However, it is clear from the literature and anecdotal evidence that most participants do not require as much opioids as we currently prescribe.

In the last few years, there have been recent initiatives to personalize post-operative pain management in orthopedic joint replacement as well as spine surgeries. In these studies, the primary consideration for opioid dosing and frequency following discharge relies on the participants' opioid requirements while in the hospital. A tapering protocol and cessation timeline following discharge is tailored for each participant based on their in-patient opioid requirements to promote opioid prescription stewardship further. These studies demonstrated a reduction in post-operative opioid consumption, with no changes in perceived pain and participants' satisfaction.

This study aims to assess the postoperative analgesic efficacy, opioid requirement, and total analgesic requirements for participants undergoing orthognathic surgery with a personalized discharge opioid prescription and tapering protocol. The study will compare two groups of participants: one group will receive the standardized prescription plan of hydromorphone, while the other group will receive a personalized prescription plan. The control will receive a standardized discharge prescription of 2-4 milligrams of liquid hydromorphone taken orally every 4 hours as needed for pain, with a total prescription of 40 milligrams of hydromorphone. The experimental group will receive a personalized hydromorphone prescription and tapering protocol for the study group. This prescription will be inferred from the participant's last 24-hour in-patient requirement of opioids before being discharged. The personalized schedule is based on a modification of a prescription schedule for spine and orthopedic joint procedures derived by Dr. Edward Mariano's group at Stanford University's Department of Anesthesiology, Perioperative and Pain Medicine.

Data will be obtained from the pre-admission appointment, and in-patient records including the nursing medication administration record (MAR), intra-operative anaesthesia records, participants' questionnaires, and the first follow-up appointment at 2 weeks. Data collected will include the participant's age, weight, body mass index, sex, pertinent medical and psychiatric history, pre-surgical anxiety, type of orthognathic surgery, length of surgery, length of stay in the hospital, amount and frequency of analgesics taken by the participants while in-hospital, analgesic dosages prescribed to the participants on discharge, amount and frequency of analgesics taken by the participants for each day following discharge, remaining prescribed opioids at the 2-week follow-up appointment, and the participant's self-reported satisfaction and pain on the Defense and Veterans Pain Rating Scale (DVPRS) questionnaire. All patient questionnaires will be recorded via REDCap, a secure online data management software.

Subjects will be stratified into single jaw surgery (i.e. LeFort only, BSSO only, +/- FG), or double jaw (i.e. LeFort and BSSO +/- FG). A Mann-Whitney U Test will be utilized for statistical analysis, with significance assumed at p < 0.05. This study is important as it will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery and also help promote opioid stewardship. ;

Related Conditions & MeSH terms

• Opioid Use
• Opioid Use Disorder
• Opioid-Related Disorders
• Orthognathic Surgery
• Pain, Postoperative
• Patient Satisfaction

• NCT number: NCT05708521
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Contact: Amr Alsabbagh, DDS
• Phone: 9024732070
• Email: alsabbaghamr@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: April 24, 2023
• Completion date: June 2026