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Clinical Trials/NCT03317600
NCT03317600
Completed
Not Applicable

Postamputation Pain: Peripheral Mechanisms

Danish Pain Research Center1 site in 1 country12 target enrollmentOctober 25, 2017

Overview

Phase
Not Applicable
Intervention
Lidocaine
Conditions
Neuropathic Pain
Sponsor
Danish Pain Research Center
Enrollment
12
Locations
1
Primary Endpoint
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2017
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Danish Pain Research Center
Responsible Party
Sponsor

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

Arms & Interventions

Lidocaine block

Intervention: Lidocaine

Isotonic saline block

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

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