Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

Not Applicable

Completed

• Conditions: Post-Operative Pain
• Interventions: Procedure: Transversus Abdominis Plane Block; Procedure: Sham Block

• Registration Number: NCT02741492
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block Group	Transversus Abdominis Plane Block	Continuous Transversus Abdominis Plane Catheter
Sham Group	Sham Block	Continuous Sham Catheter

Primary Outcome Measures

Name	Time	Method
Opioid Consumption (Intravenous Morphine Equivalents)	48 Hours	Total Opioid Consumption

Secondary Outcome Measures

Name	Time	Method
Pain (Numeric Rating)	30 Days	NRS Pain Scale
Activity Assessment Score	30 Days	Composite Score

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States