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NCT02741492 Clinical Trial

Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

Post-Operative Pain Clinical Trial

Official title:
Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02741492
Other study ID # Benaroya Research Institute
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date June 2018

Study information
Verified date July 2018
Source Benaroya Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transversus Abdominis Plane Block
Continuous Nerve Block
• Sham Block
Continuous Sham Catheter

Locations
Country Name City State
United States Virginia Mason Medical Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Opioid Consumption (Intravenous Morphine Equivalents) Total Opioid Consumption 48 Hours
Secondary Pain (Numeric Rating) NRS Pain Scale 30 Days
Secondary Activity Assessment Score Composite Score 30 Days
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