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Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

Primary Purpose

Post-Operative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transversus Abdominis Plane Block
Sham Block
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Mason Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Block Group

Sham Group

Arm Description

Continuous Transversus Abdominis Plane Catheter

Continuous Sham Catheter

Outcomes

Primary Outcome Measures

Opioid Consumption (Intravenous Morphine Equivalents)
Total Opioid Consumption

Secondary Outcome Measures

Pain (Numeric Rating)
NRS Pain Scale
Activity Assessment Score
Composite Score

Full Information

First Posted
April 12, 2016
Last Updated
July 16, 2018
Sponsor
Benaroya Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02741492
Brief Title
Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair
Official Title
Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benaroya Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Block Group
Arm Type
Active Comparator
Arm Description
Continuous Transversus Abdominis Plane Catheter
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Continuous Sham Catheter
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Intervention Description
Continuous Nerve Block
Intervention Type
Procedure
Intervention Name(s)
Sham Block
Intervention Description
Continuous Sham Catheter
Primary Outcome Measure Information:
Title
Opioid Consumption (Intravenous Morphine Equivalents)
Description
Total Opioid Consumption
Time Frame
48 Hours
Secondary Outcome Measure Information:
Title
Pain (Numeric Rating)
Description
NRS Pain Scale
Time Frame
30 Days
Title
Activity Assessment Score
Description
Composite Score
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Hanson, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31670776
Citation
Flaherty JM, Auyong DB, Yuan SC, Lin SE, Meier AW, Biehl TR, Helton WS, Slee A, Hanson NA. Continuous Transversus Abdominis Plane Block for Primary Open Inguinal Hernia Repair: A Randomized, Double-Blind, Placebo-Controlled Trial. Pain Med. 2020 Feb 1;21(2):e201-e207. doi: 10.1093/pm/pnz275.
Results Reference
derived

Learn more about this trial

Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

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