Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy

NCT02311348 | Completed

• 2 other identifiers: 15002515-DK-0025
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Disease

Keywords

Biopsy; Pain

Outcome Measures

Primary Outcomes (1)

• Pain comparison between 2 groups

  0, 2, 4, & 6 hour

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria for subject selection will include the following:
• years of age or older
• able to read, write and speak English.
• capable of providing informed consent
• subjects undergoing an elective PLB or TLB.
• baseline pain level will be assessed prior to the liver biopsy using both VAS and NPS.
• an assessment of pain threshold using a medical device called a dolorimeter.
• must be enrolled into the 91-DK-0214 protocol

You may not qualify if:

• patients who are unable to give consent will be excluded from the study.
• Patient report of a pain level of four or more pre liver biopsy
• The patient must undergo a baseline pain assessment prior to the liver biopsy using the dolorimeter.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Liver Diseases; Pain

Condition Hierarchy (Ancestors)

Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Haynes-Williams, R.N.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 8, 2014
• Study Start: November 20, 2014
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: July 2, 2017

Record last verified: 2016-12-21

Locations

US (1)