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Investigating Temporalis and Masseter Botox Injection Before Orthognathic Surgery to Improve Postoperative Pain

NCT04794504 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-03-12

No results posted yet for this study

Summary

Jaw surgery has become a very successful way to improve the appearance and functional needs of patients. Like any surgery, jaw surgery comes with a host of possible issues that patients may experience during their recovery. Although some of the most serious complications, like infections, have reliable ways to alleviate the symptoms, patients must endure several other discomforting factors. These include postoperative pain and muscle spasms. Botox® is becoming an increasingly used intervention to treat muscle related disorders (including temporomandibular disorders and chronic myofascial pain) in the head and beck region. The investigators believe that by injecting Botox® into the muscles surrounding the surgical area, patients may experience a relief in tension-related discomfort, leading to less pain and better jaw function during recovery from surgery. Further, the side effects of Botox® are either very minimal or exceedingly rare. Ultimately, Botox® may serve as a great alleviating factor with few downsides, and represent a supplementary approach to helping mitigate postoperative pain.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Botox 100 UNT Injection

Botox will be injected intramuscularly into the masseter and temporalis muscles bilaterally to investigate if it can supplement postoperative analgesia in orthognathic surgery patients

OTHER

0.9% Saline Injection

As a placebo control to the 100 UNT Botox injection, 0.9% saline will be injected intramuscularly into the masseter and temporalis muscles bilaterally

Sponsors & Collaborators

  • Kingsway Oral & Maxillofacial Surgery

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-04-19
Completion
2026-04-19
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794504 on ClinicalTrials.gov