Postamputation Pain: Peripheral Mechanisms

Neuropathic Pain Clinical Trial

Official title:

Postamputation Pain: Peripheral Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317600
• Other study ID #: Nerveblock2017
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: July 2018
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Lidocaine
Intervention is a nerve block with Lidocaine 2% with Adrenaline.

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

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	From 0 minutes until 120 minutes after injection