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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708521
• Other study ID #: 52007
• Status: Recruiting
• Phase: Phase 4
• Start date: April 24, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2023
• Source: Nova Scotia Health Authority
• Contact: Amr Alsabbagh, DDS
• Phone: 9024732070
• Email: alsabbaghamr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery
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.
• Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery
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.

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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Joo SS, Hunter OO, Tamboli M, Leng JC, Harrison TK, Kassab K, Keeton JD, Skirboll S, Tharin S, Saleh E, Mudumbai SC, Wang RR, Kou A, Mariano ER. Implementation of a patient-specific tapering protocol at discharge decreases total opioid dose prescribed for 6 weeks after elective primary spine surgery. Reg Anesth Pain Med. 2020 Jun;45(6):474-478. doi: 10.1136/rapm-2020-101324. Epub 2020 Mar 31. — View Citation

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Tamboli M, Mariano ER, Gustafson KE, Briones BL, Hunter OO, Wang RR, Harrison TK, Kou A, Mudumbai SC, Kim TE, Indelli PF, Giori NJ. A Multidisciplinary Patient-Specific Opioid Prescribing and Tapering Protocol Is Associated with a Decrease in Total Opioid Dose Prescribed for Six Weeks After Total Hip Arthroplasty. Pain Med. 2020 Nov 7;21(7):1474-1481. doi: 10.1093/pm/pnz260. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Overall satisfaction with post-surgical pain management at home	The participant's overall satisfaction with their post-surgical pain management at home as measured on the supplemental questions in the Defense and Veterans Pain Rating Scale questionnaire.; The scale measures the participants satisfaction by asking them to indicate a score from 0 to 10 for 4 items on how the pain: interferes with activity, interferes with sleep, affects overall mood, and contributes to overall stress.; A score of 0 indicates that the pain does not contribute or interfere with the aforementioned items (i.e. patient is very satisfied), while a score of 10 indicates significant contribution or interference (i.e. patient is very dissatisfied).	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.
Secondary	Mean duration of usage of opioids	The secondary outcome measure is the mean duration of usage of opioids measured in number of days used post-operatively.	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
Secondary	Total daily use of opioid by the participant	Measured as total morphine milli-equivalents (MME) per day from the questionnaire filled out by the participant. Information is cross-referenced with the total remaining opioid brought back at the follow-up visit.	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
Secondary	Average daily pain scores following discharge	The participant indicates their level of pain each time they take an analgesic medication following discharge from hospital. This is based on the Defense and Veterans Pain Rating Scale, where a score of 0 indicates no pain, while a score of 10 indicates that the pain is severe.; The average of the scores for each day is obtained and reported as the average daily pain score.	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