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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036983
Enrollment
75
Registered
2014-01-15
Start date
2013-11-30
Completion date
2015-08-31
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

Ultrasound guided TAP block with local anesthetics and dexamethasone.

PROCEDUREInstillation of surgical site with local anesthetic.

Instillation of surgical site with local anesthetics and dexamethasone.

PROCEDUREOpioid IV medications (Control)

Standard anesthetic technique.

Sponsors

VA Office of Research and Development
CollaboratorFED
Indiana University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repairPost-operatively (Day 0 to 1)Total opioid use in the post anesthesia care unit (PACU) and the period following surgery.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026