Clinical trial NCT02036983: Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Inguinal Hernia Repair
Keywords: Ultrasound guided
Bilateral Transversus abdominis Plane Block
Dexamethasone
Preperitoneal Instillation
Local Analgesic
Efficacy
Total Extraperitoneal Bilateral Inguinal hernia repair
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2014-01-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
timeFrame: Post-operatively (Day 1)
Secondary outcomes:
measure: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
timeFrame: Post-operatively (Day 0 to 1)
measure: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
timeFrame: Post-operatively (day 0)
measure: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
timeFrame: Post-operatively (day 1)
measure: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
timeFrame: Post-operatively (day 0 to 1)
measure: Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
timeFrame: Post-operatively (day 0)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush Veterans Affairs Medical Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Bryan Sakamoto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sakamoto B, Harker G, Eppstein AC, Gwirtz K. Efficacy of Local Anesthetic With Dexamethasone on the Quality of Recovery Following Total Extraperitoneal Bilateral Inguinal Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1108-1114. doi: 10.1001/jamasurg.2016.2905.