Clinical trial NCT04559048: Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
Official title: Investigation of Pain Incidence After FK506 Immunosuppressive Therapy in Liver Transplantation Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Liver Transplantation
Keywords: Chronic Pain
Liver Transplantation
FK506
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2020-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective study was conducted in patients who underwent liver transplant from September of 2011 to May of 2018 in the Liver Health Rehabilitation Association(China)

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: pain incidence
timeFrame: within 2 years after liver transplantation
measure: pain intensity
timeFrame: within 2 years after liver transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
affiliation: The Second Hospital of Tangshan
name: Dequn Liu, M.D.
role: STUDY_CHAIR
References:
citation: Reitamo S, Rustin M, Ruzicka T, Cambazard F, Kalimo K, Friedmann PS, Schoepf E, Lahfa M, Diepgen TL, Judodihardjo H, Wollenberg A, Berth-Jones J, Bieber T; European Tacrolimus Ointment Study Group. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone butyrate ointment in adult patients with atopic dermatitis. J Allergy Clin Immunol. 2002 Mar;109(3):547-55. doi: 10.1067/mai.2002.121832.
citation: Malat GE, Dupuis RE, Kassman B, Rhoads JM, Freeman K, Lichtman S, Johnson MW, Gerber D, Andreoni K, Fair J. Tacrolimus-induced pain syndrome in a pediatric orthotopic liver transplant patient. Pediatr Transplant. 2002 Oct;6(5):435-8. doi: 10.1034/j.1399-3046.2002.02030.x.