Personalization of Opioid Prescription Following Orthognathic Surgery

Phase 4

Active, not recruiting

• Conditions: Pain, Postoperative; Opioid Use; Patient Satisfaction; Orthognathic Surgery; Opioid Use Disorder

• Registration Number: NCT05708521
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-1-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Inclusion criteria<br><br> 1. Patients undergoing orthognathic surgery for the correction of dentofacial<br> deformities. Included in the study will be patients who receive single-jaw surgery<br> (i.e. BSSO [Bilateral Sagittal Split Osteotomy, a surgery of the lower jaw] only, or<br> Lefort [osteotomy of the upper jaw] only), or those in the double-jaw surgery<br> category (BSSO and Lefort).<br><br> 2. Patients undergoing a functional genioplasty who have an additional osteotomy<br> included in their surgical plan (i.e. BSSO and/or Lefort).<br><br> 3. Patients undergoing cleft orthognathic surgery.<br><br>Exclusion criteria<br><br> 1. Patients who are under the age of 18 at the time of surgery<br><br> 2. Patients who are contraindicated to undergo elective surgery, including pregnant<br> patients.<br><br> 3. Patients with a history of opioid use disorder.<br><br> 4. Patients on chronic opioids within the past month.<br><br> 5. Patients who have a contraindication for multimodal analgesia (e.g. renal injury<br> precluding the prescription of NSAIDs).<br><br> 6. Patients with allergies to opioids, acetaminophen, and/or NSAIDs.<br><br> 7. Patients receiving a surgically-assisted rapid palatal expansion (SARPE) surgery due<br> to the different post-operative nature of the surgery.<br><br> 8. Patients who have previously undergone prior orthognathic (i.e. repeat surgery),<br> non-cleft craniofacial surgery, or have previously experienced maxillofacial trauma<br> due to the potential alterations in neural pain pathways.<br><br> 9. Patients undergoing an isolated functional genioplasty.<br><br> 10. Patients who are unable to consent to surgery and/or the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fraction (%) of remaining unused opioid;Absolute amount (milligrams) of remaining unused opioid

Secondary Outcome Measures

Name	Time	Method
Overall satisfaction with post-surgical pain management at home;Mean duration of usage of opioids;Total daily use of opioid by the participant;Average daily pain scores following discharge