Postamputation Pain: Peripheral Mechanisms

Not Applicable

Completed

• Conditions: Neuropathic Pain; Amputation, Traumatic; Nerve Block; Phantom Limb Pain; Stump Pain
• Interventions: Drug: Placebo; Device: Lidocaine

• Registration Number: NCT03317600
• Lead Sponsor: Danish Pain Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Study Start: 2017-10-25
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isotonic saline block	Placebo	-
Lidocaine block	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)	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 Outcome Measures

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark