Chronic Neuropathic Pain After Nerve Repair Hand Surgery

NCT ID: NCT03174665

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 990 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

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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Conditions

Peripheral Nerve Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with Pain

Patients who had upper limb surgery or other trauma with a history of persistent spontaneous and/or evoked pain with duration of at least 3 months.

Patients will be recruited to the study by using a postal follow up questionnaire. Patients who judge their pain at least moderate and/or affecting daily life by will be eligible and asked to participate. Patients will visit the Pain Clinic once. Oral and written information about the study will be provided, informed consent obtained. The affected nerve will be identified and the anatomy verified by ultrasound when needed.

No intervention

Intervention Type: OTHER

Patients with no pain

Patients operated with nerve suture surgery after a lesion of the nerves of upper extremity will be recruited to the study by using a postal follow up questionnaire. Patients with no pain will be asked to participate. Patients will visit the Pain Clinic once. Oral and written information about the study will be provided, informed consent obtained. The affected nerve will be identified and the anatomy verified by ultrasound when needed.

No intervention

Intervention Type: OTHER

Interventions

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Adriana Miclescu

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana Miclescu, MD, PhD, DEAA

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

References

Miclescu A, Ronngren C, Bengtsson M, Gordh T, Hedin A. Increased risk of persistent neuropathic pain after traumatic nerve injury and surgery for carriers of a human leukocyte antigen haplotype. Pain. 2024 Jun 1;165(6):1404-1412. doi: 10.1097/j.pain.0000000000003143. Epub 2023 Dec 22.

Reference Type: DERIVED

PMID: 38147413 (View on PubMed)

Other Identifiers

ICONSS

Identifier Type: -

Identifier Source: org_study_id