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临床试验/NCT05708521
NCT05708521进行中(未招募)4 期

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

Nova Scotia Health Authority1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2023年4月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
201
试验地点
1
主要终点
Fraction (%) of remaining unused opioid

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery (Drug)

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.

干预措施: Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery (Drug)

结局指标

主要结局

Fraction (%) of remaining unused opioid

时间窗: 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.

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.

Absolute amount (milligrams) of remaining unused opioid

时间窗: 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.

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.

次要结局

  • 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)
  • 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.)
  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Alsabbagh

Resident in Oral and Maxillofacial Surgery, Masters Graduate Student

Nova Scotia Health Authority

研究点 (1)

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