Nervous System Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Neuralgia

Pain

Nociceptive Pain

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Oxycodone

Morphine

Analgesics, Opioid

Oxymorphone

Narcotics

Anesthetics

Oxymorphone ER

Marco Pappagallo

Marco Pappagallo, MD

This project will explore the safety and feasibility of performing a successful intravenous patient controlled analgesia (IV PCA) Oxymorphone titration and conversion to oral ER Oxymorphone (extended release or OPANA ER) in the outpatient setting.

This project will enroll 12 volunteers who suffer from chronic pain. Potential participants must be on one of the following therapies:

* Long acting morphine
* Oxycodone Participants will be asked to complete a pain diary for approximately 10 days and to stop taking their current pain medications the night before they are admitted o the GCRC. Once the patients present at the GCRC, they will be started on the IV PCA (Patient Controlled Analgesia) Oxymorphone to control their pain. Titration will take approximately a total of 8 hrs. At the end of the titration period, patients will be discharged home on OPANA ER. The oral dose will be calculated based on the IV PCA use. During the titration, patients' pain, vital and side effects will be assessed hourly until the 8th hour of the IV PCA titration.

Patients will be contacted daily by a member of the study team to assess pain and side effects. The OPANA ER dose will be adjusted as needed to adequately manage both.

If patients do not feel as though they are getting adequate pain relief, they can return to their previous medication, at which point they are considered withdrawn from the study.

Patients will undergo an exit examination 2 weeks after they were admitted to the GCRC in order to assess pain relief. In addition, a final follow-up telephone interview will take place 6 weeks after the initial 1-day stay at the GCRC. Our research staff or physicians will ask about your pain treatment and ask which Opioid medication you are currently taking.

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone

Endo Pharmaceuticals

Icahn School of Medicine at Mount Sinai

Marco Pappagallo, MD, Director of Pain Research and Development

Infections

Skin and Connective Tissue Diseases

Neoplasms

Herpes Simplex

Facies

Neuralgia, Postherpetic

Herpes Zoster

Ganglion Cysts

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

Communicable Diseases

Virus Diseases

Chickenpox

Varicella Zoster Virus Infection

Herpesviridae Infections

DNA Virus Infections

Acute Graft Versus Host Disease

Channel Blockers

Anticonvulsants

Psychotropic Drugs

Anti-Infective Agents

Pregabalin

Acyclovir

Patients will receive sham stellate ganglion block weekly for three times

Patients will receive stellate ganglion block weekly for three times with injection of 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg

While the patient is in a supine position with slight neck extension and rotation to the contralateral side, in-plane ultrasound guided stellate ganglion block will be performed with injection of 7 ml injectate (6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg).

Each patient will receive:

* Acyclovir 800 mg orally every 5 times per day 7 days.
* Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours

Stellate ganglion block

The patient will be positioned supine with slight neck extension and rotation to the contralateral side. Under US guidance, a sham stellate ganglion block will be performed with injection of a 1ml injectate of normal saline will be done while observing the dissection between the carotid artery and the longus colli muscle.

Each patient will receive:

* Acyclovir 800 mg orally every 5 times per day for 7 days.
* Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours

Sham Stellate ganglion block

Sohair Soliman, Professor

Mohamed Aly, M.D

Sameh Ismaiel, M.D

Mohamed Abduallah, M.D

Mohamed Awad, M.D

Mohamed Fouad, M.D

Patient who will be presented to Tanta University Hospitals complaining of acute herpes zoster with onset of vesicular eruption less than 7 days will be included in this clinical study.

Patients will be excluded if they refused participation, had allergy to local anesthetics, coagulopathy, local infection, glaucoma, or neurological deficit.

All the patients will receive acyclovir (antiviral therapy) and pregablin (analgesic) and the patients will be classified into two groups:- Group I (control group): Patients will receive sham block weekly for three times Group III (SGB group): Patients will receive stellate ganglion block weekly for three times

The time of first block after the onset of vesicular eruption, the incidence of PHN, NPRS at visit, duration of acute HZ , duration of PHN (if occurred), and the incidence of complication will be measured.

This prospective randomized study will be carried out on adult patients complaining of acute herpes zoster presented at Tanta University Hospitals after approval from ethics committee for twelve months.

An informed consent will be taken from each patient. All data of patients will be confidential with secret codes and private file for each patient. All given data will be used for the current medical research only.

Any unexpected risk encountered during the course of the research will be cleared to the participant as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy of the participants and confidentiality of their data.

The study will be terminated in case of incidence of severe hypotension no responding to ephedrine (Mean arterial blood pressure less than 60 mmHg) or severe bradycardia not responding to atropine (Heart rate less than 40 b/min). The participants and the ethical committee will be announced.

There will be adequate supervision to maintain the privacy of patients and confidentiality of data. There will be no conflict of interest, nor conflict with religion, law, or society standards. The research will be beneficial to the society and has no risk of environmental pollution.

After inclusion, adequate history taking, clinical examination, and laboratory investigation (as needed) will be done for all patients. Every patient will be educated about the use of the 0-10 numerical rating scale for pain assessment (NPRS: with endpoints of 'no pain' and 'worst pain').

Each patient will receive:

* Acyclovir 800 mg orally every 5 times per day (for immuno-compromised patients 10 mg/kg IV 3 times per day) for 7 days.
* Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours

Groups:

Participants will be divided into two groups; each group consists of (88) patients. The sample size calculation was made using Epi-Info software program created by the WHO

* Group I (control group): Patients will receive sham block weekly for three times
* Group II (SGB group): Patients will receive stellate ganglion block weekly for three times

Equipment

* 10-mL syringe - For local anesthetic
* 22- or 25-gauge, 1.5-inch short-bevel needle
* Skin temperature monitor
* Ultrasound machine with a 6-12 MHz linear type probe.
* Appropriate equipment and medications for medical resuscitation

Technique of SGB:

The patient will be positioned supine with slight neck extension and rotation to the contralateral side. After adequate asepsis of the neck, the probe will be placed perpendicular to tracheal axis at the cricoid cartilage. An initial scan will be obtained to identify structures: thyroid gland, carotid artery and jugular vein.

The transverse process at C6 should be identified as the initial landmark because of its prominent anterior tubercle (The Chassaignac tubercle). The long muscle of the neck (longus colli) is found above it.

The puncture should be in-plane to see the tip of the needle all the time. The needle will be directed medially until it passes through the deep cervical fascia above the longus colli muscle.

Considering repeated aspiration test, a 7 ml injectate (for SGB group: 6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg) will be done while observing the dissection between the carotid artery and the longus colli muscle.

After finishing the block:

The patient will be transferred to the recovery room for 30-60 min to assess any potential complications. After that he will be discharged.

Review appointments will be arranged weekly for 4 weeks then every 2 weeks for 4 months.

* The patients will be blind through the use of closed sealed envelops.
* The investigator will be blind through the use of sham block in the control group.
* The measurement will be collected by anesthesiologist not participating in the study and blinded to its group

Stellate Ganglion Block in Herpes Zoster

Utility of Early Serial Stellate Ganglion Block in Acute Herpes Zoster of Face and Neck

Once the study had been successfully completed, the data will be shared for other researchers.

The incidence of chronic neuropathic pain in the face or the neck after herpes zoster

The time from diagnosis of HZ till resolving of it

Mohamad Gamal Elmawy, M.D

Tanta University

Musculoskeletal Diseases

Neuroma

Morton Neuroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Metatarsalgia

Foot Diseases

Joint Diseases

Pharmaceutical Solutions

Bupivacaine

Anesthetics, Local

Analgesics, Non-Narcotic

An injection of 1-2 ml bupivacaine 0.5% will be placed around the affected branch of the neuroma (aiming at its proximal end) and dorsal adjacent tissue including the skin dorsally to the neuroma. This is to prevent pain caused by any microscopic spills of RTX during the. A second local anesthetic depot will be placed 1-2 cm proximally to the injection site around the affected branch of the plantar nerve to prevent pain caused by passive current transmission by axonal RTX excitation. Following the course of the affected nerve branch and ultra-sound visualization of the injection site, 0.5-2 ml bupivacaine 0.5% will be injected perineurally. Once the site has sufficient nerve block, the required RTX dose in a solution of 0.25 ml will be injected directly proximal to the Morton s neuroma under ultra-sound visualization.

Resiniferatoxin

Tracy S Williams, R.N.

Andrew J Mannes, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Morton s neuroma is an irritation of the nerves that affect the feet. People with this condition may have burning or shooting pain in the balls of their feet. They may also have numbness in adjacent areas. These symptoms may become more frequent and severe over time. The pain may become permanent. Current treatments tend to be short-lived, and they do not work in all people. Better treatments are needed.

Objective:

To test a study drug, resiniferatoxin (RTX), in people with Morton s neuroma.

Eligibility:

Healthy people aged 18 and older who have Morton s neuroma and have tried other standard treatments that did not ease their pain.

Design:

Participants will be involved in the study up to 4 months.

They will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have X-rays of their affected feet. They will have tests to assess their pain and how their feet react to touch and changes in temperature. They will complete questionnaires about their pain.

RTX is injected into the foot at the site of the nerve pain. Participants will receive a shot to numb the area before the RTX is administered. They will be monitored in the clinic for 4 hours after they receive the RTX.

Participants will receive up to 5 follow-up phone calls per week. Each call will take 5 to 10 minutes. They will be asked about their foot pain and whether they have had any side effects from the RTX.

Participants will return to the clinic 4 weeks after the treatment. Previous tests will be repeated.

Study Description:

This is an interventional protocol to determine the safety and tolerability of resiniferatoxin (RTX) for treatment of pain from Morton's neuroma with a single ultrasound-guided perineural injection of (RTX). It is hypothesized that RTX will provide a long-lasting reduction of the intensity of spontaneous and evoked pain and improve daily function without interfering with other sensory modalities or motor function. The safety and efficacy of the interventional procedure will be assessed during the trial. The 3+3 design of RTX treatment will be used to assess safety and determine the Dose Limiting Toxicity (DLT). Pre- and post-procedure pain intensity assessments, including graded interference of pain with daily function and graded descriptors of neuropathic pain, will be performed to assess efficacy. This protocol is intended to test RTX as a new method for long-term relief of refractory Morton s neuroma pain. Potentially this new treatment will reduce the need for radical procedures to treat unrelenting Morton s neuroma pain.

Objectives:

Primary Objective:

-To determine the safety and tolerability of resiniferatoxin (RTX) for treatment of pain from Morton's neuroma.

Secondary Objective:

-To determine the efficacy of RTX intervention on pain intensity, interference of pain with daily function and incidence and intensity of neuropathic qualities of pain.

Endpoints:

Primary Endpoint:

-The number of related Adverse Events (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) experienced between day 0 (injection day) and day 28 post-injection.

Secondary Endpoints:

* Change in average worst pain (NRS) between day 21 and day 28 compared to baseline average worst pain.
* Change in pain interference on day 28 compared to screening (preinjection) using PROMIS pain tools.

Change in neuropathic pain score on day 28 compared to screening (preinjection)using painDETECT.

Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain

Phase I Open Label Clinical Trial Using Resiniferatoxin, A Non-Opioid Medication, For the Management of Refractory Morton's Neuroma Pain

-The number of related Adverse Events (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) experienced between day 0 (injection day) and day 28 post-injection

Change in average worst pain (NRS) between day 21 and 28 compared to baseline average worst pain (NRS)

Change in pain interference on day 28 compared to screening (pre-injection) using BPI-SF

Change in neuropathic pain score on day 28 compared to screening (pre-injection) using painDETECT

National Institutes of Health Clinical Center (CC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	NCT00945919	Chronic Nocicep... Neuropathic Pai... Non-cancer Pain	Oxymorphone ER	18 Years -	Icahn School of Medicine at Mount Sinai
Stellate Ganglion Block in Herpes Zoster	NCT04188327	Pain Neuropathic	Stellate gangli... Sham Stellate g...	60 Years - 85 Years	Tanta University
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain	NCT05695339	Morton's Neurom...	Resiniferatoxin	18 Years -	National Institutes of Health Clinical Center (CC)
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain	NCT05695339	Morton's Neurom...	Resiniferatoxin	18 Years -	National Institutes of Health Clinical Center (CC)
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain	NCT05695339	Morton's Neurom...	Resiniferatoxin	18 Years -	National Institutes of Health Clinical Center (CC)
A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone	NCT00945919	Chronic Nocicep... Neuropathic Pai... Non-cancer Pain	Oxymorphone ER	18 Years -	Icahn School of Medicine at Mount Sinai
Stellate Ganglion Block in Herpes Zoster	NCT04188327	Pain Neuropathic	Stellate gangli... Sham Stellate g...	60 Years - 85 Years	Tanta University

Spots Global Cancer Trial Database for neuropathic

Every month we try and update this database with for neuropathic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for neuropathic

Every month we try and update this database with for neuropathic cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for neuropathic cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.