Liver Disease Clinical Trial
Official title:
Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
Verified date | December 21, 2016 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver biopsy
(PLB) is done through a needle on the right side of your belly. In a transjugular liver
biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in. The tube
goes down to your liver and a piece of liver is removed. Researchers want to learn more about
the pain people feel after each of these procedures.
Objectives: To compare whether there is more pain associated with the PLB versus TLB.
Eligibility: Adults 18 years or older enrolled in a separate protocol (91-DK-0214) for liver
biopsy. They must be able to read, write, and speak English.
Design: Under the separate protocol (91-DK-0214), participants will be screened and have a
liver biopsy.
Before the biopsy, participants will give their medical history. They will answer questions
about past surgeries and how they feel about pain.
Participants will have a pain test with a device called a dolorimeter. They will sit up with
their feet on the ground, and put their thumbs on a table. They will feel pressure on each
thumb until it they say it is painful.
Before the biopsy and 2, 4, and 6 hours after the biopsy, they will answer pain questions.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 21, 2016 |
Est. primary completion date | December 21, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA: Criteria for subject selection will include the following: 1. 18 years of age or older 2. able to read, write and speak English. 3. capable of providing informed consent 4. subjects undergoing an elective PLB or TLB. 5. baseline pain level will be assessed prior to the liver biopsy using both VAS and NPS. 6. an assessment of pain threshold using a medical device called a dolorimeter. 7. must be enrolled into the 91-DK-0214 protocol EXCLUSION CRITERIA: 1. patients who are unable to give consent will be excluded from the study. 2. Patient report of a pain level of four or more pre liver biopsy 3. The patient must undergo a baseline pain assessment prior to the liver biopsy using the dolorimeter. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain comparison between 2 groups | 0, 2, 4, & 6 hour |
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