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

Not Applicable

Completed

• Conditions: Bilateral Inguinal Hernia Repair
• Interventions: Procedure: Transversus abdominis plane block (TAP BLOCK); Procedure: Instillation of surgical site with local anesthetic.; Procedure: Opioid IV medications (Control)

• Registration Number: NCT02036983
• Lead Sponsor: Indiana University School of Medicine

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-08
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound guided bilateral TAP block	Transversus abdominis plane block (TAP BLOCK)	Ultrasound guided TAP Block with local anesthetic and dexamethasone.
Instillation of surgical site with local anesthestic.	Instillation of surgical site with local anesthetic.	Instillation of surgical site under direct visualization with local anesthetics and dexamethasone.
Control Group	Opioid IV medications (Control)	Standard anesthetic technique

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair	Post-operatively (day 0)	Time spent in the PACU

Trial Locations

Locations (1)

Richard L. Roudebush Veterans Affairs Medical Center; 🇺🇸 Indianapolis, Indiana, United States