Abdominal Wall Block Study

NCT ID: NCT03074240

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2021-07-12

Brief Summary

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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

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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

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Umbilical Hernia Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAPB Group

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.

Group Type ACTIVE_COMPARATOR

TAPB Group

Intervention Type PROCEDURE

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.

conversion to general anesthesia

Intervention Type PROCEDURE

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

RSB Group

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.

Group Type ACTIVE_COMPARATOR

RSB Group

Intervention Type PROCEDURE

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 anesthesia

Intervention Type PROCEDURE

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

Interventions

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TAPB Group

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

RSB Group

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

conversion to general anesthesia

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

Intervention Type PROCEDURE

Other Intervention Names

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truncal peripheral nerve blocks anesthetize the abdominal wall ultrasound-guided regional anesthesia Transversus abdominis plane blocks truncal peripheral nerve blocks anesthetize the abdominal wall ultrasound-guided regional anesthesia rectus sheath blocks general anesthetic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José R Soberón, MD

Role: PRINCIPAL_INVESTIGATOR

Malcom Randall VA Medical Center

Locations

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Malcom Randall VA Medical Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OCR18951

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201602387 - V

Identifier Type: -

Identifier Source: org_study_id

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