Umbilical HerniaTAPBNCT03074240
Abdominal Wall Block Study
A study testing TAPB Group, RSB Group and conversion to general anesthesia in people with Umbilical Hernia and Obesity, run by University of Florida at 1 site in United States.
Trial summary
Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Umbilical Hernia, Obesity
- What is being tested?
- TAPB Group, RSB Group and conversion to general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to 12 Jul 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age undergoing umbilical hernia repair
- Overweight and obese individuals (defined as a body mass index of ≥ 25 and 30 kg/m2, respectively)
- Ability to understand and provide informed consent
Who cannot join
- Patient refusal or inability to provide informed consent
- True allergy, not sensitivity, local anesthetics
- True allergy, not sensitivity, Propofol
- True allergy, not sensitivity, general anesthetic agents
- Pregnancy
- Severe hepatic impairment
Show all 9Show fewer
- Evidence of infection at or near the proposed needle insertion site
- Any sensorimotor deficit, whether acute or chronic, as determined by the PI
- Chronic use of opioid medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
About this study
Official title: A Prospective and Randomized Comparison of Ultrasound-guided Transversus Abdominis Plane Versus Rectus Sheath Blocks as a Primary Anesthetic for Abdominal Wall Surgery in Adults.
Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.
Read the detailed description
The purpose of this research study is to compare the ability of the TAPB and RSB to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. It is not known if these blocks could be used to avoid the use of general anesthesia.
- Conditions
- Umbilical Hernia, Obesity
- Being tested
- TAPB Group, RSB Group, conversion to general anesthesia
- Keywords
- Truncal block, Surgical anesthesia, Postoperative pain control
- Medical subject headings
- Hernia, Umbilical, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPB GroupProcedure or surgery
Also called truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, Transversus abdominis plane blocks
Subjects allocated to the TAPB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.
RSB GroupProcedure or surgery
Also called truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, rectus sheath blocks
Subjects allocated to the RSB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.
conversion to general anesthesiaProcedure or surgery
Also called general anesthetic
For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.
| Study group | Role | What they receive |
|---|---|---|
| TAPB Group | Active comparator | Compare the instance in the TAPB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing TAPB to anesthetize the abdominal wall. Receives: Procedure: TAPB Group; Procedure: conversion to general anesthesia |
| RSB Group | Active comparator | Compare the instance in the RSB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing RSB to anesthetize the abdominal wall. Receives: Procedure: RSB Group; Procedure: conversion to general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between the two groups to provide surgical anesthesia
Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia
Measured: Changes from baseline (pre-op) to 1 hour post-operative
Secondary outcomes (1)
Changes between the two groups assessed by post-operative pain control
Assessed by instances of numerical rating scale pain scores (0-10)
Measured: Changes from baseline (post-operative) to 48 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start7 Aug 2017
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Parallel groups
- Model description
- Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- José R Soberón, MD, Principal investigator, Malcom Randall VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074240
- Sponsor's protocol ID
- IRB201602387 - V
- Other IDs
- OCR18951
- Acronym
- TAPB
- Status last verified
- May 2024
- First submitted
- 3 Mar 2017
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Randomized Comparison of Ultrasound-guided Transversus Abdominis Plane Versus Rectus Sheath Blocks as a Primary Anesthetic for Abdominal Wall Surgery in Adults.
- ClinicalTrials.gov ID
- NCT03074240
- Acronym / sponsor ID
- TAPB / IRB201602387 - V
- Conditions
- Umbilical Hernia, Obesity
- Keywords
- Truncal block, Surgical anesthesia, Postoperative pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 8 Mar 2017 (actual)
- 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.
Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.
Detailed description
The purpose of this research study is to compare the ability of the TAPB and RSB to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. It is not known if these blocks could be used to avoid the use of general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
| Arm | Type | Receives |
|---|---|---|
| TAPB Group | Active comparator | Procedure: TAPB Group, Procedure: conversion to general anesthesiaCompare the instance in the TAPB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing TAPB to anesthetize the abdominal wall. |
| RSB Group | Active comparator | Procedure: RSB Group, Procedure: conversion to general anesthesiaCompare the instance in the RSB group of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia when undergoing RSB to anesthetize the abdominal wall. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years of age undergoing umbilical hernia repair
- Overweight and obese individuals (defined as a body mass index of ≥ 25 and 30 kg/m2, respectively)
- Ability to understand and provide informed consent
Key exclusion criteria (9 listed)
- Patient refusal or inability to provide informed consent
- True allergy, not sensitivity, local anesthetics
- True allergy, not sensitivity, Propofol
- True allergy, not sensitivity, general anesthetic agents
- Pregnancy
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 |
|---|---|---|
| TAPB GroupAlso: truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, Transversus abdominis plane blocksSubjects allocated to the TAPB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared. | Procedure or surgery | TAPB Group |
| RSB GroupAlso: truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, rectus sheath blocksSubjects allocated to the RSB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared. | Procedure or surgery | RSB Group |
| conversion to general anesthesiaAlso: general anestheticFor those who do not respond to TAPB or RSB to allow for completion of the intended procedure. | Procedure or surgery | RSB Group, TAPB Group |
Primary outcome
Changes between the two groups to provide surgical anesthesia
Time frame: Changes from baseline (pre-op) to 1 hour post-operative
Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia
1 secondary outcome
Changes between the two groups assessed by post-operative pain control
Time frame: Changes from baseline (post-operative) to 48 hours post-operative
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 30 May 2024.
- Individual participant dataSharing planned: No
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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.
José R Soberón, MD principal investigator
Malcom Randall VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAPB Group, RSB Group and conversion to general anesthesia in people with Umbilical Hernia and Obesity, run by University of Florida 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 9 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 30 May 2024. 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. 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?
Changes between the two groups to provide surgical anesthesia (time frame: Changes from baseline (pre-op) to 1 hour post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2024.