Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02311348
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2014-12-05
Brief Title:
Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
Status:
COMPLETED
Status Verified Date:
2016-12-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-DK-0025 | None | None | None |