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
1 other identifier
interventional
75
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJune 6, 2018
August 1, 2016
1.7 years
December 5, 2013
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery.
Post-operatively (Day 1)
Secondary Outcomes (5)
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 to 1)
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)
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)
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 to 1)
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)
Study Arms (3)
Ultrasound guided bilateral TAP block
ACTIVE COMPARATORUltrasound guided TAP Block with local anesthetic and dexamethasone.
Instillation of surgical site with local anesthestic.
ACTIVE COMPARATORInstillation of surgical site under direct visualization with local anesthetics and dexamethasone.
Control Group
PLACEBO COMPARATORStandard anesthetic technique
Interventions
Ultrasound guided TAP block with local anesthetics and dexamethasone.
Instillation of surgical site with local anesthetics and dexamethasone.
Eligibility Criteria
You may qualify if:
- yrs of age
- American Society of Anesthesiologists (ASA) physical status 1-3
- Scheduled for outpatient TEP bilateral inguinal hernia repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 27653293DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Sakamoto, M.D.
Indiana University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2013
First Posted
January 15, 2014
Study Start
November 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 6, 2018
Record last verified: 2016-08