Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair

June 1, 2018 updated by: Indiana University School of Medicine

Comparison of an Ultrasound Guided Bilateral Transversus Abdominis Plane Block With Dexamethasone and Preperitoneal Instillation of Local Anesthetic With Dexamethasone to a Standard Anesthetic Technique for Analgesic Efficacy and Patient Satisfaction Following a Total Extraperitoneal Bilateral Inguinal Hernia Repair: A Prospective Randomized Single Blinded Study

Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under direct visualization will be compared it to a standard anesthetic technique (control) following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are hypothesizing that the bilateral TAP block and preperitoneal instillation of local anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction and post-operative pain control when compared to a standard anesthetic technique (no regional technique).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Richard L. Roudebush Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 yrs of age
  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Scheduled for outpatient TEP bilateral inguinal hernia repair

Exclusion Criteria:

  • Patients refusal to participate
  • inability to give consent
  • drug allergies to medications used in study
  • pregnancy
  • bleeding diathesis
  • conversion to an open procedure
  • any subject whose anatomy, or surgical procedure, in the opinion of the investigator might preclude the potential successful performance of a TAP block
  • any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound guided bilateral TAP block
Ultrasound guided TAP Block with local anesthetic and dexamethasone.
Procedure: Transversus abdominis plane block (TAP BLOCK)
Ultrasound guided TAP block with local anesthetics and dexamethasone.
Active Comparator: Instillation of surgical site with local anesthestic.
Instillation of surgical site under direct visualization with local anesthetics and dexamethasone.
Procedure: Instillation of surgical site with local anesthetic.
Instillation of surgical site with local anesthetics and dexamethasone.
Placebo Comparator: Control Group
Standard anesthetic technique
Procedure: Opioid IV medications (Control)
Standard anesthetic technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time Frame: Post-operatively (Day 1)
Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery.
Post-operatively (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time Frame: Post-operatively (Day 0 to 1)
Total opioid use in the post anesthesia care unit (PACU) and the period following surgery.
Post-operatively (Day 0 to 1)
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time Frame: Post-operatively (day 0)
Pain scores in the PACU
Post-operatively (day 0)
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time Frame: Post-operatively (day 1)
Pain scores post-operatively.
Post-operatively (day 1)
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time Frame: Post-operatively (day 0 to 1)
Any side effects secondary to any of the post-operative pain procedures.
Post-operatively (day 0 to 1)
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time Frame: Post-operatively (day 0)
Time spent in the PACU
Post-operatively (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

VA Office of Research and Development

Investigators

  • Principal Investigator: Bryan Sakamoto, M.D., Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308124192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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