NCT02741492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

April 12, 2016

Last Update Submit

July 16, 2018

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption (Intravenous Morphine Equivalents)

    Total Opioid Consumption

    48 Hours

Secondary Outcomes (2)

  • Pain (Numeric Rating)

    30 Days

  • Activity Assessment Score

    30 Days

Study Arms (2)

Block Group

ACTIVE COMPARATOR

Continuous Transversus Abdominis Plane Catheter

Procedure: Transversus Abdominis Plane Block

Sham Group

SHAM COMPARATOR

Continuous Sham Catheter

Procedure: Sham Block

Interventions

Transversus Abdominis Plane BlockPROCEDURE

Continuous Nerve Block

Block Group
Sham BlockPROCEDURE

Continuous Sham Catheter

Sham Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral open inguinal hernia repair
  • ASA physical status I-III
  • \>18 years old
  • Consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Flaherty JM, Auyong DB, Yuan SC, Lin SE, Meier AW, Biehl TR, Helton WS, Slee A, Hanson NA. Continuous Transversus Abdominis Plane Block for Primary Open Inguinal Hernia Repair: A Randomized, Double-Blind, Placebo-Controlled Trial. Pain Med. 2020 Feb 1;21(2):e201-e207. doi: 10.1093/pm/pnz275.

    PMID: 31670776DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Neil A Hanson, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 18, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

US(1)