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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Bilateral Inguinal Hernia Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound guided bilateral TAP block

Ultrasound guided TAP Block with local anesthetic and dexamethasone.

Group Type ACTIVE_COMPARATOR

Transversus abdominis plane block (TAP BLOCK)

Intervention Type PROCEDURE

Ultrasound guided TAP block with local anesthetics and dexamethasone.

Instillation of surgical site with local anesthestic.

Instillation of surgical site under direct visualization with local anesthetics and dexamethasone.

Group Type ACTIVE_COMPARATOR

Instillation of surgical site with local anesthetic.

Intervention Type PROCEDURE

Instillation of surgical site with local anesthetics and dexamethasone.

Control Group

Standard anesthetic technique

Group Type PLACEBO_COMPARATOR

Opioid IV medications (Control)

Intervention Type PROCEDURE

Standard anesthetic technique.

Interventions

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Transversus abdominis plane block (TAP BLOCK)

Ultrasound guided TAP block with local anesthetics and dexamethasone.

Intervention Type PROCEDURE

Instillation of surgical site with local anesthetic.

Instillation of surgical site with local anesthetics and dexamethasone.

Intervention Type PROCEDURE

Opioid IV medications (Control)

Standard anesthetic technique.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes