Bilateral Inguinal Hernia RepairNCT02036983
Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair
A study testing Transversus abdominis plane block (TAP BLOCK) and Instillation of surgical site with local anesthetic. in people with Bilateral Inguinal Hernia Repair, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Inguinal Hernia Repair
- What is being tested?
- Transversus abdominis plane block (TAP BLOCK) and Instillation of surgical site with local anesthetic.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 yrs of age
- American Society of Anesthesiologists (ASA) physical status 1-3
- Scheduled for outpatient TEP bilateral inguinal hernia repair
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, 46202
About this study
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
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).
- Conditions
- Bilateral Inguinal Hernia Repair
- Being tested
- Transversus abdominis plane block (TAP BLOCK), Instillation of surgical site with local anesthetic., Opioid IV medications (Control)
- Keywords
- Ultrasound guided, Bilateral Transversus abdominis Plane Block, Dexamethasone, Preperitoneal Instillation, Local Analgesic, Efficacy, Total Extraperitoneal Bilateral Inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane block (TAP BLOCK)Procedure or surgery
Ultrasound guided TAP block with local anesthetics and dexamethasone.
Instillation of surgical site with local anesthetic.Procedure or surgery
Instillation of surgical site with local anesthetics and dexamethasone.
Opioid IV medications (Control)Procedure or surgery
Standard anesthetic technique.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided bilateral TAP block | Active comparator | Ultrasound guided TAP Block with local anesthetic and dexamethasone. Receives: Procedure: Transversus abdominis plane block (TAP BLOCK) |
| Instillation of surgical site with local anesthestic. | Active comparator | Instillation of surgical site under direct visualization with local anesthetics and dexamethasone. Receives: Procedure: Instillation of surgical site with local anesthetic. |
| Control Group | Placebo comparator | Standard anesthetic technique Receives: Procedure: Opioid IV medications (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Total opioid use in the post anesthesia care unit (PACU) and the period following surgery.
Measured: 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
Pain scores in the PACU
Measured: 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
Pain scores post-operatively.
Measured: 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
Any side effects secondary to any of the post-operative pain procedures.
Measured: 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
Time spent in the PACU
Measured: Post-operatively (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bilateral Inguinal Hernia RepairStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Bryan Sakamoto, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036983
- Sponsor's protocol ID
- 1308124192
- Status last verified
- Aug 2016
- First submitted
- 5 Dec 2013
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27653293
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02036983
- Acronym / sponsor ID
- 1308124192
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided bilateral TAP block | Active comparator | Procedure: Transversus abdominis plane block (TAP BLOCK)Ultrasound guided TAP Block with local anesthetic and dexamethasone. |
| Instillation of surgical site with local anesthestic. | Active comparator | Procedure: Instillation of surgical site with local anesthetic.Instillation of surgical site under direct visualization with local anesthetics and dexamethasone. |
| Control Group | Placebo comparator | Procedure: Opioid IV medications (Control)Standard anesthetic technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 yrs of age
- American Society of Anesthesiologists (ASA) physical status 1-3
- Scheduled for outpatient TEP bilateral inguinal hernia repair
Key exclusion criteria (8 listed)
- Patients refusal to participate
- inability to give consent
- drug allergies to medications used in study
- pregnancy
- bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus abdominis plane block (TAP BLOCK)Ultrasound guided TAP block with local anesthetics and dexamethasone. | Procedure or surgery | Ultrasound guided bilateral TAP block |
| Instillation of surgical site with local anesthetic.Instillation of surgical site with local anesthetics and dexamethasone. | Procedure or surgery | Instillation of surgical site with local anesthestic. |
| Opioid IV medications (Control)Standard anesthetic technique. | Procedure or surgery | Control Group |
Primary outcome
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time frame: Post-operatively (Day 1)
Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery.
5 secondary outcomes
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post-operatively (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 27653293Sakamoto 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.
Related trials for Bilateral Inguinal Hernia Repair
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
Not yet recruiting
Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias
Inguinal Hernia Bilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Sakamoto, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block (TAP BLOCK) and Instillation of surgical site with local anesthetic. in people with Bilateral Inguinal Hernia Repair, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair (time frame: Post-operatively (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02036983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.