Postamputation Pain: Peripheral Mechanisms

NCT ID: NCT03317600

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Neuropathic Pain Amputation, Traumatic Nerve Block Phantom Limb Pain Stump Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lidocaine block

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DEVICE

Intervention is a nerve block with Lidocaine 2% with Adrenaline.

Isotonic saline block

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intervention is a "placebo" nerve block with isotonic saline

Interventions

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Lidocaine

Intervention is a nerve block with Lidocaine 2% with Adrenaline.

Intervention Type DEVICE

Placebo

Intervention is a "placebo" nerve block with isotonic saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Danish Pain Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danish Pain Research Center, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Nerveblock2017

Identifier Type: -

Identifier Source: org_study_id

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