N/A
N=8
Peripheral Sensory Input in Central Post Stroke Pain (CPSP)
Central Post Stroke Pain
Bottom Line
View on ClinicalTrials.gov: NCT02148588 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. — 6.5; 0.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound-guided peripheral nerve block with 2% lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. |
6.5; 0.0 | — |
| SECONDARY Change in the Intensity of Cold Sensation |
7; 0.0 | — |
| SECONDARY Change in the Intensity of Warm Sensation |
5.9; 0.5 | — |
| SECONDARY Change in the Intensity of Pinprick Sensation |
5.0; 1.1 | — |
| SECONDARY Change in the Intensity of Brush Sensation |
4.5; 1.0 | — |
| SECONDARY Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire |
4.1; 0.0; 2.6; 0.0; 3.6; 0.9 | — |
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.
Eligibility Criteria
Each subject must meet all of the following criteria:
- Age ≥18;
- CPSP affecting an upper or a lower limb, in a distribution that may be completely covered by a peripheral nerve block;
- Patient fulfills all mandatory criteria for CPSP, fulfills at least one supportive criteria, and has definite CPSP by probability grading.
- Pain duration at least 3 months;
- Spontaneous pain intensity (average pain in past week) of ≥ 4 on 0-10 Numerical Rating Scale (NRS).
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02148588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.