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

Recruiting

• Conditions: Chronic Pain; Liver Transplantation
• Interventions: Drug: FK506

• Registration Number: NCT04559048
• Lead Sponsor: The Second Hospital of Tangshan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-15
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-03-15
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pain incidence	within 2 years after liver transplantation	Pain is defined as painful sensation that lasts or recurs for 1-3 months within 3 months after liver transplantation, or for longer than 3 months within 12 months after liver transplantation.
pain intensity	within 2 years after liver transplantation	Pain is reported subjectively by the patient using the visual analogue scale (VAS)

Trial Locations

Locations (1)

The Second Hospital of Tangshan; 🇨🇳 Tangshan, Hebei, China