Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Block Group

Continuous Transversus Abdominis Plane Catheter

Group Type ACTIVE_COMPARATOR

Transversus Abdominis Plane Block

Intervention Type PROCEDURE

Continuous Nerve Block

Sham Group

Continuous Sham Catheter

Group Type SHAM_COMPARATOR

Sham Block

Intervention Type PROCEDURE

Continuous Sham Catheter

Interventions

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Transversus Abdominis Plane Block

Continuous Nerve Block

Intervention Type PROCEDURE

Sham Block

Continuous Sham Catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes