Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neuralgia

Pain

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Bone Density Conservation Agents

Pregabalin

Amitriptyline

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Anti-Anxiety Agents

Antidepressive Agents

Antidepressive Agents, Tricyclic

Analgesics, Non-Narcotic

Adrenergic Agents

Neurotransmitter Agents

Strategy in which patient starts with amitriptyline

Strategy in which patient starts with pregabalin

strategy in which the patient starts with amitriptyline, during 8 weeks

amitriptyline

pregabalin

Yvonne Engels, PhD

Annelies Schalkwijk, MSc

Roberto Perez, PhD

Carin vd Rijt, MD, PhD

Kris Vissers, MD PhD FIPP

Rationale: Often, incurable cancer patients suffer from severe symptoms as (neuropathic) pain and fatigue with polypharmaceutic interventions as a consequence. Regarding neuropathic pain in incurable cancer patients, pregabalin has been registered for neuropathic non-cancer pain, and amitriptyline is not registered for neuropathic pain, but is recommended as the drug of first choice in the Dutch handbooks of palliative care. As a consequence of an adaptation of a Dutch law (July 2007) about off-label medication prescription, off-label medication is not allowed anymore unless a standard or protocol exists. No clinical trials for this patient group have been published before.

Objective: To compare efficacy, side effects and costs of a strategy with amitriptyline as drug of first choice versus a strategy with pregabalin as drug of first choice.

Study design: An open label, randomised non-inferiority trial Study population: Incurable cancer patients with neuropathic pain Intervention: When a patient decides to take part in the study, he will be allocated randomly to one of the two study groups. A minimisation algorithm will be used, that balances for the cause of neuropathic pain (tumour related versus treatment related), type of treatment (ongoing chemo- or radiotherapy versus not ongoing chemo- or radiotherapy) and institution. Each drug will be prescribed in a step up procedure. Patients will be followed during 8 weeks.

Main study parameters/endpoints: Neuropathic pain, as measured with the mean VAS and McGill questionnaire, strategy success, costs per strategy, side effects, quality of life and concomitant analgesic drugs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are hardly any risks for the patients. The drugs in both arms already are usual care for the target population. If there is no or a too small effect, the drug of the other arm will be added, which strategy also is already usual care. All other medication, except for Tricyclic Antidepressants Drugs (TADs) and Anti Epileptic Drugs (AEDs), as well as radiotherapy and chemotherapy are allowed. The patient has to visit the hospital 2 times during the study period. The patient had to fill in a pain diary daily (5 min), cost diary and EQ-5D every other week (10 min), related questionnaires as HADS, McGill and EORTC-QLQ-C30 monthly (20 min).

Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer

A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective

Erasmus Medical Center

University of Amsterdam

Radboud University Medical Center

K.C.P. Vissers MD, PhD, FIPP

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anesthetics

Bupivacaine

Anesthetics, Local

Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine

16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block

Ultrasound guided delivery of local anesthetic between the pectoral muscles

PECS block

Nelun Wijayasinghe, MBBS, BSc

Kenneth G Andersen, MD, PhD

Henrik Kehlet, MD, PhD, DMsc

This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.

This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.

Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery

Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery

Patients will complete a pain diary for 5 consecutive days before administration of the PECS block and 7 consecutive days after the block. The patients also complete a functional questionnaire the day before the block and again exactly one week after the block.

SPI is a combination of pain at rest + pain on arm abduction + pain with 100kPa pressure. SPI will be taken before and 30 minutes after the PECS block

QST consists of sensory mapping (delineating areas of hypo/hyperesthesia and/or allodynia), warm detection thresholds, cool detection thresholds, heat pain thresholds, suprathermal heat pain response and pressure pain thresholds. These will be measured before and 30 minutes after the PECS block

Kehlet, Henrik, M.D., Ph.D.

Rigshospitalet, Denmark

Anesthesiologist, clinical researcher

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Amitriptyline or Pregabalin to Treat Neuropathic Pain in Incurable Cancer	NCT00740571	Cancer Neuralgia	amitriptyline pregabalin	18 Years -	Radboud University Medical Center
Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery	NCT02349581	Persistent Pain...	PECS block Bupivacaine	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for neuralgia

Every month we try and update this database with for neuralgia 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 neuralgia

Every month we try and update this database with for neuralgia 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 neuralgia 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.