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Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02741492
Enrollment
90
Registered
2016-04-18
Start date
2016-04-30
Completion date
2018-06-30
Last updated
2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Operative Pain

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.

Interventions

PROCEDURETransversus Abdominis Plane Block

Continuous Nerve Block

PROCEDURESham Block

Continuous Sham Catheter

Sponsors

Benaroya Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid Consumption (Intravenous Morphine Equivalents)48 HoursTotal Opioid Consumption

Secondary

MeasureTime frameDescription
Pain (Numeric Rating)30 DaysNRS Pain Scale
Activity Assessment Score30 DaysComposite Score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026