Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

NCT02148588 | Completed Results

• 1 other identifier: 201405121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.

Conditions

Central Post Stroke Pain

Keywords

Central Post Stroke Pain; Nerve block

Outcome Measures

Primary Outcomes (1)

• Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.

  Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents "no pain", and 10 represents "worst pain imaginable"

  baseline and 30 minutes

Secondary Outcomes (5)

• Change in the Intensity of Cold Sensation

  baseline and 30 min

• Change in the Intensity of Warm Sensation

  baseline and 30 min

• Change in the Intensity of Pinprick Sensation

  baseline and 30 min

• Change in the Intensity of Brush Sensation

  baseline and 30 min

• Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire

  baseline and 40 min

Study Arms (1)

Pain testing

EXPERIMENTAL

Completion of NPSI questionnaire Sensory mapping of the affected limb Quantitative Sensory Testing Patients will have a peripheral nerve blockade

Drug: Ultrasound-guided peripheral nerve block with 2% lidocaine

Interventions

Ultrasound-guided peripheral nerve block with 2% lidocaine DRUG

Patients will have a peripheral nerve blockade with a local anesthetic (lidocaine) Assessment of spontaneous and evoked pain responses Completion of NPSI questionnaire Mapping of the affected limb

Pain testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects will not be enrolled if any of the following criteria exist:
• Not giving consent to participate in the study;
• Significant psychiatric or cognitive impairment;
• Moderate to severe renal or liver failure;
• Concomitant treatment with warfarin or other anticoagulants;
• Pregnancy or lactation.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Simon Haroutounian
• Organization: Washington University School of Medicine

simon.haroutounian@wustl.edu

3142861715

Study Officials

• Simon Haroutounian, PHD

  Washington Univesity School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 28, 2014
• Study Start: August 1, 2014
• Primary Completion: December 15, 2016
• Study Completion: January 25, 2017
• Last Updated: May 2, 2018
• Results First Posted: May 2, 2018

Record last verified: 2018-04

Locations

US (1)