Bilateral Inguinal Hernia Repair Clinical Trial
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
| NCT number | NCT02036983 |
| Other study ID # | 1308124192 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2013 |
| Est. completion date | August 2015 |
| Verified date | August 2016 |
| Source | Indiana University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Indiana University School of Medicine | VA Office of Research and Development |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Post-operatively (Day 0 to 1) | |
| Secondary | 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 | Post-operatively (day 0) | |
| Secondary | 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. | Post-operatively (day 1) | |
| Secondary | 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. | Post-operatively (day 0 to 1) | |
| Secondary | 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 | Post-operatively (day 0) |