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Abdominal Wall Block Study (TAPB)

Primary Purpose

Umbilical Hernia, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TAPB Group

RSB Group

conversion to general anesthesia

About this trial

This is an interventional treatment trial for Umbilical Hernia focused on measuring Truncal block, Surgical anesthesia, Postoperative pain control

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Malcom Randall VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

TAPB Group

RSB Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes between the two groups to provide surgical anesthesia

Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia

Secondary Outcome Measures

Changes between the two groups assessed by post-operative pain control

Assessed by instances of numerical rating scale pain scores (0-10)

Full Information

NCT ID

NCT03074240

First Posted

March 3, 2017

Last Updated

January 3, 2022

Sponsor

University of Florida

Collaborators

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT03074240

Brief Title

Abdominal Wall Block Study

Acronym

TAPB

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

August 7, 2017 (Actual)

Primary Completion Date

July 12, 2021 (Actual)

Study Completion Date

July 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Umbilical Hernia, Obesity

Keywords

Truncal block, Surgical anesthesia, Postoperative pain control

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAPB Group

Arm Type

Active Comparator

Arm Description

Arm Title

RSB Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

TAPB Group

Other Intervention Name(s)

truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, Transversus abdominis plane blocks

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

RSB Group

Other Intervention Name(s)

truncal peripheral nerve blocks, anesthetize the abdominal wall, ultrasound-guided regional anesthesia, rectus sheath blocks

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

conversion to general anesthesia

Other Intervention Name(s)

general anesthetic

Intervention Description

For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.

Primary Outcome Measure Information:

Title

Changes between the two groups to provide surgical anesthesia

Description

Assessed by the ability of the TAPB and RSB to provide primary surgical anesthesia

Time Frame

Changes from baseline (pre-op) to 1 hour post-operative

Secondary Outcome Measure Information:

Title

Changes between the two groups assessed by post-operative pain control

Description

Assessed by instances of numerical rating scale pain scores (0-10)

Time Frame

Changes from baseline (post-operative) to 48 hours post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José R Soberón, MD

Organizational Affiliation

Malcom Randall VA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Malcom Randall VA Medical Center

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Abdominal Wall Block Study

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