Transversus Abdominus Plane Catheters for Open Inguinal H... | NCT02741492

Studies
Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

NCT02741492

Sponsor

Benaroya Research Institute

Status

Completed

Last Update Posted

Jul 18, 2018Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Post-Operative Pain

Interventions

Transversus Abdominis Plane Block
Sham Block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Apr 12, 2016

First Submission Date that Met QC Criteria

Apr 13, 2016

First Posted Date

Apr 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2018

Last Update Posted Date

Jul 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Block Group	Active Comparator	Continuous Transversus Abdominis Plane Catheter	Procedure: Transversus Abdominis Plane Block
Sham Group	Sham Comparator	Continuous Sham Catheter	Procedure: Sham Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transversus Abdominis Plane Block	Procedure	Continuous Nerve Block	Block Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Opioid Consumption (Intravenous Morphine Equivalents)	Total Opioid Consumption	48 Hours

Secondary Outcomes

Measure	Description	Time Frame
Pain (Numeric Rating)	NRS Pain Scale	30 Days
Activity Assessment Score	Composite Score	30 Days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil A Hanson, MD	Virginia Mason Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Mason Medical Center		Seattle	Washington	98101	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31670776	Derived	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain