Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

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.
    

Detailed description: 
      Millions of Americans are diagnosed with some form of Hepatitis or other liver disease
      requiring treatment. Liver biopsies are frequently performed mainly to stage disease, aid in
      diagnosis and to guide treatment. As part of the assessment of Hepatitis patients, a liver
      biopsy is frequently part of the regimen. Liver biopsy procedures can be performed using one
      of two methods: percutaneous liver biopsy (PLB) or transjugular liver biopsy (TLB). Alknawy &
      Shiffman (2007) discuss approaches of percutaneous liver biopsy that included the
      percussion-palpation approach, image guided, ultrasound assisted, ultrasound guided and type
      of biopsy needle used. The method of liver biopsy selected will not be randomly assigned but
      will be determined by the hepatologist caring for the patient. Pain can be a complication
      following a liver biopsy requiring adequate pain management.

      Despite an extensive review of previous studies, none were found that discussed the pain
      experiences of patients who have undergone PLB versus TLB. This study proposes to compare the
      amount of pain experienced by patients who have undergone PLB versus TLB. Thirty-two male and
      female patients age 18 years and older who meet study criteria will be invited to
      participate. The participants will be placed into either the PLB or TLB group with each group
      consisting of 16 male or 16 female participants. Prior to the biopsy and within the first 6
      hours post procedure, at the 2, 4 and 6-hour time points, the patient will be asked to rate
      their pain on the Visual Analogue Scale (VAS) and on the Numeric Pain Scale (NPS).
      Additionally, the dolorimeter will be used pre liver biopsy along with the VAS and the NPS as
      standardized pain measurements.
    

Observational model: Case-Control
Time perspective: Prospective
Keywords: Biopsy; Pain