Lidocaine for Myofibroma

Phase-Based Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MO
Myofibroma+5 More
Lidocaine - Drug
Eligibility
18+
Female
Eligible conditions
Myofibroma

Study Summary

This study is evaluating whether patients who receive intrathecal morphine with intraoperative lidocaine infusion have lower opioid consumption than patients who receive epidural anesthesia with patient controlled analgesia.

See full description

Eligible Conditions

  • Myofibroma
  • Leiomyoma
  • Fibroid Uterus
  • Cancer Debulking
  • Enlarged Uterus
  • Adnexal Masses

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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).

At 6 week follow-up
Rate of persistent pain
Day 4
Patient satisfaction with pain control
Day 4
Length of hospital stay
Week 6
Rate of deep vein thrombosis (DVT)
Rate of pulmonary thromboembolism (PTE)
Day 4
Morphine milligram equivalent (MME) in the postoperative hospital course
Rate of postoperative ileus
Week 6
Change in pain scores
Through day 30
30 day readmission rate
Hour 48
Rate of postoperative hypotension

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)
Intrathecal morphine with intraoperative lidocaine infusion

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.

Intrathecal morphine with intraoperative lidocaine infusionDay or surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg) Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight Day of surgery postoperative: toradol, ibuprofen, tylenol Postoperative: ibuprofen, oxycodone, and hydromorphone prn
Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)
Drug
Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol. Intraoperative: dexamethasone and epidural bupivacaine Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine Postoperative: hydromorphone PCA, ibuprofen, oxycodone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Morphine
FDA approved
Lidocaine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 hours after surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 48 hours after surgery for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Lab values must be ≤1.5x normal for preoperative work-up. show original
You are female and are 18 years of age or older. show original
You are undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service. show original
Platelets > 100 K/cumm
You have a hemoglobin level of 8.0 g/dl or higher. show original
You have a serum creatinine level of <1.5 mg/dl. show original
Creatinine clearance (CrCl) ≥30 ml/min/1.73 m2. show original
You have a normal (within the reference range) INR.\n show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the latest developments in lidocaine for therapeutic use?

Add answer

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.

Unverified Answer

Does myofibroma run in families?

Add answer

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.

Unverified Answer

What are common treatments for myofibroma?

Add answer

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.

Unverified Answer

Does lidocaine improve quality of life for those with myofibroma?

Add answer

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.

Unverified Answer

What is myofibroma?

Add answer

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.

Unverified Answer

Is lidocaine safe for people?

Add answer

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.

Unverified Answer

How quickly does myofibroma spread?

Add answer

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.

Unverified Answer

How serious can myofibroma be?

Add answer

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.

Unverified Answer

What are the common side effects of lidocaine?

Add answer

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.

Unverified Answer

What is the primary cause of myofibroma?

Add answer

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.

Unverified Answer

Who should consider clinical trials for myofibroma?

Add answer

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.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Myofibroma by sharing your contact details with the study coordinator.