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

Indiana University School of Medicine

Status: Completed

Conditions: Bilateral Inguinal Hernia Repair

Treatments: Procedure: Opioid IV medications (Control); Procedure: Instillation of surgical site with local anesthetic.; Procedure: Transversus abdominis plane block (TAP BLOCK)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02036983

1308124192

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 3 patient groups, including a placebo group

Ultrasound guided bilateral TAP block

Active Comparator group

Description:

Ultrasound guided TAP Block with local anesthetic and dexamethasone.

Treatment:

Procedure: Transversus abdominis plane block (TAP BLOCK)

Instillation of surgical site with local anesthestic.

Active Comparator group

Description:

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

Treatment:

Procedure: Instillation of surgical site with local anesthetic.

Control Group

Placebo Comparator group

Description:

Standard anesthetic technique

Treatment:

Procedure: Opioid IV medications (Control)