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Postamputation Pain: Peripheral Mechanisms

Primary Purpose

Neuropathic Pain, Amputation, Traumatic, Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
Danish Pain Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuropathic Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danish Pain Research Center, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine block

Isotonic saline block

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
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).

Full Information

First Posted
October 13, 2017
Last Updated
July 12, 2018
Sponsor
Danish Pain Research Center
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03317600
Brief Title
Postamputation Pain: Peripheral Mechanisms
Official Title
Postamputation Pain: Peripheral Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Pain Research Center
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Amputation, Traumatic, Nerve Block, Phantom Limb Pain, Stump Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine block
Arm Type
Active Comparator
Arm Title
Isotonic saline block
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Lidocaine
Intervention Description
Intervention is a nerve block with Lidocaine 2% with Adrenaline.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intervention is a "placebo" nerve block with isotonic saline
Primary Outcome Measure Information:
Title
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
Description
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).
Time Frame
From 0 minutes until 120 minutes after injection
Secondary Outcome Measure Information:
Title
Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
Description
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).
Time Frame
From 0 minutes until 120 minutes after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Postamputation Pain: Peripheral Mechanisms

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