Postamputation Pain: Peripheral Mechanisms
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedStudy Start
First participant enrolled
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedJuly 16, 2018
July 1, 2018
4 months
October 13, 2017
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
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).
From 0 minutes until 120 minutes after injection
Secondary Outcomes (1)
Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
From 0 minutes until 120 minutes after injection
Study Arms (2)
Lidocaine block
ACTIVE COMPARATORIsotonic saline block
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).
You may not qualify if:
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
- Allergy to Lidocaine or similar analgetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Danish Pain Research Centerlead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 23, 2017
Study Start
October 25, 2017
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
July 16, 2018
Record last verified: 2018-07