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OpenTrials
Completed

NCT Number: NCT02741492

Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

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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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversus abdominis plane block

Procedure

Continuous Nerve Block

Sham Block

Procedure

Continuous Sham Catheter

Primary outcomes

  1. Opioid Consumption (Intravenous Morphine Equivalents)

    Time frame: 48 Hours

    Total Opioid Consumption

Secondary outcomes

  1. Pain (Numeric Rating)

    Time frame: 30 Days

    NRS Pain Scale

  2. Activity Assessment Score

    Time frame: 30 Days

    Composite Score

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Registry information

Official study title

Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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