Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/24/2016 |
| Start Date: | November 2014 |
| End Date: | December 2016 |
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.
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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