ClinicalTrials.gov
ClinicalTrials.gov Menu

Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02741492
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Neil Hanson, Benaroya Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-Operative Pain Procedure: Transversus Abdominis Plane Block Procedure: Sham Block Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair
Study Start Date : April 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Block Group
Continuous Transversus Abdominis Plane Catheter
Procedure: Transversus Abdominis Plane Block
Continuous Nerve Block
Sham Comparator: Sham Group
Continuous Sham Catheter
Procedure: Sham Block
Continuous Sham Catheter



Primary Outcome Measures :
  1. Opioid Consumption (Intravenous Morphine Equivalents) [ Time Frame: 48 Hours ]
    Total Opioid Consumption


Secondary Outcome Measures :
  1. Pain (Numeric Rating) [ Time Frame: 30 Days ]
    NRS Pain Scale

  2. Activity Assessment Score [ Time Frame: 30 Days ]
    Composite Score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741492


Contacts
Contact: Neil A Hanson, MD neil.hanson@virginiamason.org
Contact: David b Auyong, MD david.auyong@virginiamason.org

Locations
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Neil A Hanson, MD       neil.hanson@virginiamason.org   
Contact: David B Auyong, MD       david.auyong@virginiamason.org   
Sponsors and Collaborators
Benaroya Research Institute
Investigators
Principal Investigator: Neil A Hanson, MD Virginia Mason Medical Center

Responsible Party: Neil Hanson, Staff Anesthesiologist, Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT02741492     History of Changes
Other Study ID Numbers: Benaroya Research Institute
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Hernia
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pathological Conditions, Anatomical