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Completed

NCT Number: NCT02036983

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

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).

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Key information

Conditions

Bilateral Inguinal Hernia Repair

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush Veterans Affairs Medical Center

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Transversus abdominis plane block (TAP block)

Procedure

Ultrasound guided TAP block with local anesthetics and dexamethasone.

Instillation of surgical site with local anesthetic.

Procedure

Instillation of surgical site with local anesthetics and dexamethasone.

Opioid IV medications (Control)

Procedure

Standard anesthetic technique.

Primary outcomes

  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 1)

    Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery.

Secondary outcomes

  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)

    Total opioid use in the post anesthesia care unit (PACU) and the period following surgery.

  2. 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

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • VA Office of Research and Development

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2014
Registry last updated
Jun 6, 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.