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Postamputation Pain: Peripheral Mechanisms

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ClinicalTrials.gov Identifier: NCT03317600
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Danish Pain Research Center

Brief Summary:
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Amputation, Traumatic Nerve Block Phantom Limb Pain Stump Pain Device: Lidocaine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Postamputation Pain: Peripheral Mechanisms
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine block Device: Lidocaine
Intervention is a nerve block with Lidocaine 2% with Adrenaline.

Placebo Comparator: Isotonic saline block Drug: Placebo
Intervention is a "placebo" nerve block with isotonic saline




Primary Outcome Measures :
  1. Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain) [ Time Frame: From 0 minutes until 120 minutes after injection ]
    The patient will be asked about spontaneous pain, including stump and phantom pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain).


Secondary Outcome Measures :
  1. Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain). [ Time Frame: From 0 minutes until 120 minutes after injection ]
    The patient will be asked about evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain). Evoked pain is triggered by a SOMEDIC brush, thermo rolls (20 degrees Celcius and 40 degrees Celcius) and pinprick with a von Frey filament (60 g).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).

Exclusion Criteria:

  • Severe somatic or psychiatric diseases
  • Other peripheral neuropathy
  • Lack of ability to cooperate to the clinical examination
  • Allergy to Lidocaine or similar analgetics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317600


Locations
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Denmark
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
Aarhus University Hospital

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Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT03317600     History of Changes
Other Study ID Numbers: Nerveblock2017
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuralgia
Phantom Limb
Amputation, Traumatic
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action