This trial is evaluating whether Lidocaine will improve 1 primary outcome and 9 secondary outcomes in patients with Myofibroma. Measurement will happen over the course of Postoperatively while patient is in hospital (estimated to be 4 days).
This trial requires 174 total participants across 2 different treatment groups
This trial involves 2 different treatments. Lidocaine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
The current data show that lidocaine has a low toxicity profile in the clinical setting, and therefore represents a safe and effective topical analgesic that can reduce procedural discomfort and postoperative pain. Application of lidocaine in combination with articular injections of local anesthetics leads to improved outcomes.
The association of MFS and MFM with family history suggests a genetic component to this disease. Further studies should be performed to investigate the role of hereditary factors in these diseases.
Because myofibroma is not completely understood, there is no specific therapy used for the disorder. A combination of surgery with limited radiation therapy has been reported to yield good results.
Subjective patient satisfaction with cosmetic outcome is excellent after one application of topical 5% lidocaine cream. Although there were no statistically significant differences between the two groups, the patients reported improved aesthetic outcomes with lidocaine treatment.
Fibromyalgia, dermatomyositis, polymyositis, systemic sclerosis, lupus erythematosus, rheumatoid arthritis, sarcoidosis, Graves' disease, Crohn's disease, temporal arteritis, or amyloidosis should be included in the differential diagnosis of a palpable, solitary, painless, subcutaneous nodule. Myofibroma may occur anywhere in the body, but it is usually found in the extremities. Myofibroma is an uncommon tumor characterized by a fibroblastic proliferation composed of stellate cells with bundles of collagen. The epithelial component of this lesion consists of type I and III collagens.
In this retrospective study, there was no evidence of increased local side effects following topical injection of 0.5% lidocaine solution applied to the skin overlying the myofibroma. However, it cannot be excluded that lidocaine may have caused delayed reactions after its long-term exposure. Given that most cases of myofibroma occur in children under 10 years of age, further studies are required to determine whether long-term lidocaine use is associated with any adverse effects on skeletal growth.
Myofibroma has a very aggressive potential to grow rapidly and metastasize throughout the body within a short period of time. In addition to local invasion, it will invade adjacent tissues, blood vessels, lymphatic system, and other organs, resulting in severe complications. Patients should be informed about the need for early wound closure and the necessity of immediate surgery to prevent recurrence.
Myofibroma is a benign intra-abdominal tumor that accounts for approximately 1% of all abdominal tumors. The majority of cases occur in infants and young children under 2 years old; however, they can be found in all age groups. Usually, myofibroma will slowly grow over time, and if left untreated, can eventually rupture and spread outside of its original site. If left untreated, this disease can lead to death. Patients with suspected myofibroma should have an MRI, CT scan, ultrasound, or biopsy done to confirm the diagnosis. Treatments for myofibroma usually include surgery, chemotherapy, radiation therapy, and more.
Lidocaine can produce transient myocardial dysfunction when used intravenously or intrarectally in doses >2 mg/kg. This cardiac toxicity may be dose dependent and reversible on discontinuation of lidocaine infusion. Lidocaine-induced myocardial dysfunction should be included among the rare side effects of lidocaine.
The most common primary cause of myofibroma is [a benign tumor of connective tissue, called a fibroma]](http://www.dartmouth.edu/~tweissert/tweissert/dermatology/dermatopathology/fibroma_handheld.pdf). Other causes include fibromatosis, neurofibroma, dermatofibrosarcoma protuberans, angiofibroma, Paget's disease, and sarcoidosis, among others.
Patients should be encouraged to consider randomized clinical trials if there is high suspicion of malignancy; however, it is difficult to identify appropriate candidates because of difficulties in differentiating benign from malignant tumors.