Nervous System Diseases

Symptoms and General Pathology

All Conditions

Mouth and Tooth Diseases

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Neuralgia

Headache

Trigeminal Neuralgia

Ganglion Cysts

Synovial Cyst

Headache Disorders

Cysts

Pain

Neurologic Manifestations

Peripheral Nervous System Diseases

Neuromuscular Diseases

Mucinoses

Connective Tissue Diseases

Trigeminal Nerve Diseases

Facies

Facial Neuralgia

Facial Nerve Diseases

Mouth Diseases

Stomatognathic Diseases

Cranial Nerve Diseases

Brain Diseases

Central Nervous System Diseases

All Drugs and Chemicals

Vasodilator Agents

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

The patients will be injected with 25 IU of Botulinum Toxin Type A towards the sphenopalatine ganglion in the affected side (ipsilateral to the pain)

Botulinum Toxin Type A

Erling A Tronvik, PhD, MD

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.

Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.

Number of adverse events. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.

expressed as score on Visual analogue scale (VAS) for pain

St. Olavs Hospital

Norwegian University of Science and Technology

Behaviors and Mental Disorders

Pain, Postoperative

Breast Neoplasms

Breast Diseases

Postoperative Complications

Skin Diseases

Quality of Life

Pharmaceutical Solutions

100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast

5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast

5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A

Placebo

Valerie Lemaine, MD

Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast reconstruction. Implant-based breast reconstruction is frequently achieved in two-stages. The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of biweekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and high patient satisfaction. Despite the well-recognized advantages of this successful breast reconstruction technique, the subpectoral placement of a tissue expander is associated with significant pain and discomfort in the immediate post-operative period and during the phase of tissue expansion. Pectoralis major muscle spasm is a frequently reported problem during tissue expansion. Legeby et al. recently showed that women who underwent prosthetic breast reconstruction had higher pain scores and took more analgesics that those who did not choose post-mastectomy reconstruction.

In the past 10 years, publications on the use of botulinum toxin A (BTX-A) for pain relief in a wide array of clinical conditions have increased tremendously. BTX-A is one of the neurotoxins produced by Clostridium botulinum bacteria. By reversibly inhibiting neurotransmitter release, BTX-A has both analgesic and paralytic properties. The analgesic action of BTX-A was initially thought to be related to its effects on muscular contraction. However, a recent in vitro study of embryonic rat dorsal neurons did confirm that BTX-A inhibits release of substance P, a neurotransmitter associated with pain and inflammatory reactions. The presence of analgesic properties of BTX-A is increasingly supported by several clinical observations: pain relief with BTX-A injections has been reported for migraine headaches, chronic pelvic, chronic tennis elbow, and post-operative pain control for lower limb lengthening correction, among others.

This aspect has never been studied in breast cancer survivors who elect to pursue breast reconstruction with tissue expanders. Furthermore, physical function outcomes are important to consider with BTX-A use because the link between temporary muscle paralysis and improvements in participation in daily activities is not a given.

The investigators propose to complete a double-blinded prospective randomized controlled trial of women undergoing unilateral and bilateral mastectomies with immediate placement of tissue expanders, to establish the efficacy and safety of BTX-A in alleviating pain and in improving physical well-being during the expansion period.

Consecutively enrolled eligible women will be randomized into one of two different treatment groups: 1) Group receiving BTX-A, and 2) Group receiving a placebo. All consenting subjects will be randomized to receive either a single injection of 100 units of BTX-A, or a placebo (saline water), during surgery in the pectoralis major muscle on the operated side once the mastectomy and the breast reconstruction have been completed. Expected duration of subject participation is 4 months.

Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial

The numeric pain intensity scale (NPIS) will be completed at the preoperative visit and again at the first postoperative visit. The NPIS is a visual analog scale (VAS) commonly used to assess clinical pain. Subjects are asked to rate their pain on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

The Physical Well-Being scale of the BREAST-Q, Reconstruction module, will be used for this purpose. The BREAST-Q is a validated patient-reported outcome measure to accurately assess quality of life and patient satisfaction. The Reconstruction module Physical Well-Being scale has questions on the function and participation in activities before and after breast reconstruction. For this study, subjects were asked to answer 16 questions on how often they experienced each symptom, using score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80) for each patient at each visit. Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.

The amount of initial intraoperative fill volume in milliliters (mL) in the tissue expander at the time of surgery divided by the manufacturers recommended total tissue expander volume will be measured. Each breast will be measured separately.

The total number of tissue expansion visits completed post-operatively.

Measurement of total expansion volume in milliliters (mL).

The rate of reconstruction failure will be measured by the number of subjects who have tissue expander removal.

Allergan

Mayo Clinic

Principal Investigator

100 Units of Botulinum toxin A diluted in 5 mL 0.9% Sodium Chloride (NaCl) in the pectoralis major muscle in each operated breast

Botulinum Toxin Type A

Group A - Botulinum Toxin Type A

5 mL 0.9% NaCl injection to the pectoralis major muscle in each operated breast

Placebo: 5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A

Group B - Placebo

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Body Mass Index (BMI)

A practice change from patients receiving paravertebral blocks preoperatively to intraoperative field blocks with liposomal bupivacaine;data not collected on postoperative oral narcotic consumption;study designed to detect 25% decrease in pain score.

Dr. Valerie Lemaine, MD, MPH

Change From Baseline in Average Pain Scores Using a Numeric Pain Intensity Scale

Physical Well-Being Using the BREAST-Q, Reconstruction Module

Right breast initial percent volume expansion

Left breast initial percent volume expansion

Right breast

Left breast

Volume measurements were not captured for all subjects.

Initial Intraoperative Fill Volume in Milliliters (mL)

Number of Tissue Expansion Visits

Volume measurement were not captured on all subjects.

Total Volume of Tissue Expansion

Rate of Reconstruction Failure

Overall Study

Cluster Headache

Trigeminal Autonomic Cephalalgias

Headache Disorders, Primary

Chronic Graft Versus Host Disease

Micronutrients

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Retinol

5 patients will be injected with 25 IU of Botulinum Toxin Type A towards the otic ganglion in the symptomatic side (ipsilateral to the pain)

5 patients will be injected with 12.5 IU of Botulinum Toxin Type A towards the otic ganglion in the symptomatic side (ipsilateral to the pain)

injection with 25 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device

Botulinum Toxin Type A 25 IU

injection with 12.5 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device

Botulinum Toxin Type A 12.5 IU

Lars Jacob Stovner, prof MD

Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of the most severe pains known to man, having a large impact on the sufferer's quality of life. A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been a target for treatment of primary headache disorders for more than a century but there are several anatomic and physiologic studies that suggest that another cranial parasympathetic ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster headache. Recruitment of patients will be solely in Norway. There is no data available to determine the correct dosage of botulinum toxin. A similar neural structure that has been blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU. Even though the number of treated patients is low, there did not appear to be differences in the adverse events profile between those who received 25 Iu and those who received 50 IU. The investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25 IU of botulinum toxin.

Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues

All adverse events will be registered. The likelihood of a relationship between the AE and the pharmacological substance or the procedure will be evaluated. Data will be collected from the headache diary (free text) and open questions at the office follow up visits.

Number of cluster headache attacks per week

number of days without cluster headache attacks

The headache intensity is registered in the headache diary using a scale from 0-5

Mean number of attacks with intensity grade 4-5

The functional level will be assessed by the WHO Performance Status

Triptan use per 4 weeks during the whole duration of the study

the number of analgesic doses per 4 weeks during the whole duration of the study

Absenteeism due to cluster headache as assessed by the headache diary

as assessed by a qualitative questionnaire (HIT-6)

assessed on Cranial Autonomic Parasympathetic Symptoms (CAPS) scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.	NCT02662972	Trigeminal Neur... Headache Disord...	Botulinum Toxin...	18 Years - 80 Years	Norwegian University of Science and Technology
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.	NCT02662972	Trigeminal Neur... Headache Disord...	Botulinum Toxin...	18 Years - 80 Years	Norwegian University of Science and Technology
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction	NCT01591746	Breast Cancer Pain, Postopera... BRCA1 Mutation BRCA2 Mutation Breast Diseases Neoplasms	Botulinum Toxin... Placebo	18 Years -	Mayo Clinic
Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues	NCT03066635	Cluster Headach...	Botulinum Toxin... Botulinum Toxin...	18 Years - 70 Years	Norwegian University of Science and Technology

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