Clinical trial NCT03174665: Chronic Neuropathic Pain After Nerve Repair Hand Surgery
Official title: Incidence of Chronic Neuropathic Pain and Sensory Deficits After Nerve Repair Hand Surgery (Correlation With Genotypes and Biomarkers)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Nerve Injuries
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2017-06-02
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients opererated with nerve suture surgery on Hand Surgery between 2006-2014

Brief summary: This study intends to compare the patients with pain with those who underwent same procedure without developing pain. The patients with pain and without pain will be further analyzed in respect to clinical differences, biomarkers and genetical differences.

Detailed description: Chronic pain is a well-known complication after surgery, but the prevalence of persistent pain after upper extremity surgery or other trauma affecting the radial, ulnar or the medial nerve, or branches of these nerves such as digital nerves is unknown. The reason that some patients develop persistent neuropathic pain after surgery, while others, who have been through the exact same procedure or trauma, are pain free is still unknown. The underlying mechanisms are still largely unknown. This can lead to different responses to treatment. Whenever possible, it is important to identify and address the underlying pain mechanisms in the individual patient in order to design an optimal treatment.

The aim of this study was to determine the prevalence and the factors implicated in the development of persistent pain after nerve suture surgery investigating Clinical symptoms, standardized clinical examination for neuropathic pain, 92 biomarkers special developed for neuropathic pain, genetics.

Conditioned pain modulation and Cold pressor test is intend to be performed in all the patients.

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Eligibility criteria: Exclusion Criteria:

* Other condition that may confound assessment of pain attributed to posttraumatic upper limb pain, as judged by the investigator
* Any condition/disease that could interfere with the study measurements, e.g. peripheral vascular disease, diabetes mellitus, polyneuropathy etc as judged by the investigator

Inclusion Criteria:

* • Female or male subjects \> 18 years of age

  * Provision of written informed consent
  * Be able to understand and comply with the requirements of the study
  * Patients with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement) interfering with daily activities of at least 3 months duration, associated with upper extremity surgery or other trauma affecting the radial, ulnar, medial or digital nerve
  * Spontaneous or evoked pain upon standardized test (mechanical, movement)\> 50 on a 100 mm VAS scale in the group with pain after nerve repair surgery and a group of patients with no pain

Primary outcomes:
measure: Prevalence of neuropathic pain after trauma and nerve suture surgery
timeFrame: 2016 january-2017 january
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University Hospital
name: Adriana Miclescu, MD, PhD, DEAA
role: PRINCIPAL_INVESTIGATOR
References: