Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients

The Second Hospital of Tangshan

Status: Enrolling

Conditions: Liver Transplantation; Chronic Pain

Treatments: Drug: FK506

Study type: Observational

Funder types: Other

Identifiers

NCT04559048

HBTS1411206

Details and patient eligibility

About

FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation, and to treat T cell-mediated diseases such as eczema and atopic dermatitis. FK506 treatment often accompanies pain sensation in patients with atopic dermatitis or after organ transplantation. In previous studies, the investigators confirmed that FK506 treatment increased neuronal activity of primary afferent neurons and causes pain behavior in naïve mice. In order to further search for objective clinical evidence, the investigators proposed to investigate pain incidence after FK506 immunosuppressive therapy in liver transplantation patients. The investigators will investigate pain incidence and pain intensity in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association. The patients who were divided into two groups based on whether or not FK506 was used in the immunosuppressive therapy. The patients in control group (without FK506 treatment) and FK506-treated group report pain sensation 3 months and 12 months after liver transplant. The investigators will compare the pain incidence between the two groups at both time points. On the other hand, the investigators will further investigate changes in pain sensation after 1st and 2nd reductions of FK506 dose. Pain is reported subjectively by the patient using the visual analogue scale (VAS) 1 month after dose reduction. In our study, 1st and 2nd reductions of FK506 dose refers to the first two dose-adjustments (approximately 6 months apart) that occurred 3-6 months after the liver transplantation.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. had liver transplantation for end-stage liver disease
2. was ≥18 years of age at the time of liver transplantation -

Exclusion criteria

1. liver cancer
2. acute (fulminant) liver failure
3. multiorgan transplant
4. chronic postsurgical pain
5. fibromyalgia, osteoarthritis, low back pain and inflammatory pain of any origin
6. peripheral and central neuropathic pain of any origin
7. chronic secondary visceral pain
8. chronic cancer-related pain that is due to cancer or its treatment -

Trial design

300 participants in 2 patient groups

FK506-treated group

Description:

In FK506-treated group, the patients who underwent liver transplant are treated with FK506 immunosuppressive therapy.

Treatment:

Drug: FK506

control group without FK506 treatment

Description:

In control group, the patients who underwent liver transplant are treated without FK506.