Back to resultsComparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair
Primary Purpose
Bilateral Inguinal Hernia Repair
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transversus abdominis plane block (TAP BLOCK)
Instillation of surgical site with local anesthetic.
Opioid IV medications (Control)
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Inguinal Hernia Repair focused on measuring Ultrasound guided, Bilateral Transversus abdominis Plane Block, Dexamethasone, Preperitoneal Instillation, Local Analgesic, Efficacy, Total Extraperitoneal Bilateral Inguinal hernia repair
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
Sites / Locations
- Richard L. Roudebush Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Ultrasound guided bilateral TAP block
Instillation of surgical site with local anesthestic.
Control Group
Arm Description
Ultrasound guided TAP Block with local anesthetic and dexamethasone.
Instillation of surgical site under direct visualization with local anesthetics and dexamethasone.
Standard anesthetic technique
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Total opioid use in the post anesthesia care unit (PACU) and the period following surgery.
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Pain scores in the PACU
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Pain scores post-operatively.
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Any side effects secondary to any of the post-operative pain procedures.
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time spent in the PACU
Full Information
NCT ID
NCT02036983
First Posted
December 5, 2013
Last Updated
June 1, 2018
Sponsor
Indiana University School of Medicine
Collaborators
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02036983
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Inguinal Hernia Repair
Keywords
Ultrasound guided, Bilateral Transversus abdominis Plane Block, Dexamethasone, Preperitoneal Instillation, Local Analgesic, Efficacy, Total Extraperitoneal Bilateral Inguinal hernia repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided bilateral TAP block
Arm Type
Active Comparator
Arm Description
Ultrasound guided TAP Block with local anesthetic and dexamethasone.
Arm Title
Instillation of surgical site with local anesthestic.
Arm Type
Active Comparator
Arm Description
Instillation of surgical site under direct visualization with local anesthetics and dexamethasone.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Standard anesthetic technique
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block (TAP BLOCK)
Intervention Description
Ultrasound guided TAP block with local anesthetics and dexamethasone.
Intervention Type
Procedure
Intervention Name(s)
Instillation of surgical site with local anesthetic.
Intervention Description
Instillation of surgical site with local anesthetics and dexamethasone.
Intervention Type
Procedure
Intervention Name(s)
Opioid IV medications (Control)
Intervention Description
Standard anesthetic technique.
Primary Outcome Measure Information:
Title
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Description
Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery.
Time Frame
Post-operatively (Day 1)
Secondary Outcome Measure Information:
Title
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Description
Total opioid use in the post anesthesia care unit (PACU) and the period following surgery.
Time Frame
Post-operatively (Day 0 to 1)
Title
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Description
Pain scores in the PACU
Time Frame
Post-operatively (day 0)
Title
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Description
Pain scores post-operatively.
Time Frame
Post-operatively (day 1)
Title
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Description
Any side effects secondary to any of the post-operative pain procedures.
Time Frame
Post-operatively (day 0 to 1)
Title
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Description
Time spent in the PACU
Time Frame
Post-operatively (day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Sakamoto, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush Veterans Affairs Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27653293
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.
Results Reference
derived
Links:
URL
https://jamanetwork.com/journals/jamasurgery/fullarticle/2553477
Description
Efficacy of Local Anesthetic With Dexamethasone on the Quality of Recovery Following Total Extraperitoneal Bilateral Inguinal Hernia RepairA Randomized Clinical Trial
Learn more about this trial
Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair
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