- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741492
Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair
July 16, 2018 updated by: Neil Hanson, Benaroya Research Institute
Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair
This study is designed to evaluate pain control of continuous transversus abdominis plane (TAP) blocks placed for open inguinal hernia repair.
The investigators hypothesize that there will be improved pain control when compared with sham blocks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized, controlled trial designed to determine whether continuous transversus abdominis plane (TAP) block versus sham block has a substantial impact on pain following open inguinal hernia repair.
Our primary outcome is to determine whether there will be a difference in opioid consumption within the first two days following surgery.
Secondary outcomes will include: pain scores and activity assessment score.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unilateral open inguinal hernia repair
- ASA physical status I-III
- >18 years old
- Consent to participate in the study
Exclusion Criteria:
- Refusal to participate in the study
- <18 years old
- Chronic opioid use
- Localized infection
- Pregnancy or lactating
- Pre-existing coagulopathy or active anticoagulant use
- Allergy to ultrasound gel or local anesthetics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Block Group
Continuous Transversus Abdominis Plane Catheter
|
Continuous Nerve Block
|
Sham Comparator: Sham Group
Continuous Sham Catheter
|
Continuous Sham Catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption (Intravenous Morphine Equivalents)
Time Frame: 48 Hours
|
Total Opioid Consumption
|
48 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Numeric Rating)
Time Frame: 30 Days
|
NRS Pain Scale
|
30 Days
|
Activity Assessment Score
Time Frame: 30 Days
|
Composite Score
|
30 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil A Hanson, MD, Virginia Mason Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
April 12, 2016
First Submitted That Met QC Criteria
April 13, 2016
First Posted (Estimate)
April 18, 2016
Study Record Updates
Last Update Posted (Actual)
July 18, 2018
Last Update Submitted That Met QC Criteria
July 16, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Benaroya Research Institute
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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