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Healthy VolunteersNCT06955013

Ultrasound to View Abdominal Wall Muscle Layers

An observational study of Healthy Volunteers, run by Corewell Health South at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The American College of Emergency Physicians (ACEP) views ultrasound-guided nerve blocks to be a core skill for emergency medicine physicians. They are used widely, commonly for various traumatic injuries, both for repair/stabilization of injuries, as well as for pain control while awaiting definitive management. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
How many people
118 participants
Where
1 siteUnited States
Study dates
25 Aug 2025to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of adult patients aged 18 and over who visit an academic community emergency department (ED) with an annual volume of approximately 69,000 patients. These patients are approached by emergency medicine residents during their ultrasound rotation and are asked to participate in the study.

Who may be able to join

  • Age: Adult patients aged 18 and over
  • Willingness to participate: Patients who are willing to undergo the ultrasound procedure and provide written informed consent

Who cannot join

  • Age: Pediatric patients (under 18 years old)
  • Consent: Patients unable to sign consent for themselves, including non-English speakers, patients with dementia or altered mental status
  • At-Risk Populations: Pregnant patients, prisoners, and minors
  • Infectious Considerations: Patients under isolation precautions or with open wounds/skin injury in the abdominal/flank area

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Corewell Health Lakeland

    Saint Joseph, Michigan, 49085

    Recruiting

Other trials in United States

About this study

Official title: Ability of Emergency Medicine Doctors to Use Ultrasound to View Muscle Layers of the Abdominal Wall

The American College of Emergency Physicians (ACEP) views ultrasound-guided nerve blocks to be a core skill for emergency medicine physicians. They are used widely, commonly for various traumatic injuries, both for repair/stabilization of injuries, as well as for pain control while awaiting definitive management. Ultrasound is often used to identify specific nerves or fascial planes to guide deposition of local anesthetic. Some of these blocks include interscalene brachial plexus blocks to help manage shoulder dislocation, supraclavicular brachial plexus nerve blocks to help manage elbow dislocation or distal wrist fracture reductions, fascia iliaca plane block for pain control of hip fractures patients awaiting definitive surgery, and serratus anterior plane block to help manage rib fracture pain. As these techniques become more mainstream due to increasing focus upon them in residency training and improvements in ultrasound technology, research upon these blocks has increased dramatically since 2016, with most of these articles focusing on hip fracture and shoulder dislocation.

The abdominal musculature of the flank is comprised of the external oblique muscle, internal oblique muscle, and the transversus abdominis. Branches of the lateral cutaneous nerve pass between the internal oblique muscle innervating the peritoneum. First described in the anesthesia literature in 2001, transversus abdominis plane (TAP) block has been found to decrease narcotic requirement after abdominal surgery by targeting these branches. It has also been found to be effective when performed by surgeons. However, it has been only minimally alluded to in the emergency medicine literature.

Read more

Obesity can have a negative effect on image procurement in ultrasound. Given how little TAP blocks have been reviewed in the emergency medicine literature, even less is known about emergency physicians' ability to deal with added difficulties brought by increases in body habitus. Some anesthesia teachers recommend out-of-plane needle approaches in obese patients rather than in-plane needle approaches for less challenging body habituses. Ultrasound-guided TAP blocks have been used successfully in bariatric surgery, so there is precedent for use in this population.

The study proposes to evaluate emergency medicine physician ability to obtain images suitable for potential TAP block administration in patients with varying body habitus. The hypothesis is that while potential TAP block could be limited by increased body habitus, the majority of patients would still be able to potentially undergo the procedure.

Methods Approval for this study will be sought from the Lakeland IRB. This is a prospective study conducted at an academic community emergency department with a volume of about 69,000 annually. Patients were approached by emergency medicine residents on their ultrasound rotation with regards to willingness to participate in the study and written informed consent was obtained. Inclusion criteria were adult patients aged 18 and over who were willing to undergo the informal ultrasound looking to identify the muscular layers with enough definition that a TAP block could be carried out. No injection of medication was carried out in this study. Exclusion criteria included pediatric patients, patients unable to sign consent for themselves (including non-English speakers, patients with dementia or altered mental status), as well as populations potentially at risk (such as pregnant patients, prisoners, and minors). Patients with infectious considerations were excluded (such as those under isolation precautions or with open wounds/skin injury in the abdominal/flank area).

If patients were willing to participate, residents assigned patients a study number and recorded basic demographic information (age, sex, race, ethnicity, and Body Mass Index (BMI)). Residents then carried out the ultrasound starting with the linear array probe at the level of the umbilicus, fanning laterally to identify the rectus sheath and then the shared aponeurosis for the internal oblique and transversus abdominis muscle. The resulting image of the abdominal wall was then recorded, saved under the patient's study identification number, and saved digitally to the study folder maintained on hospital servers. Patients were only enrolled once. Patients were analyzed for differences in the rates of obtaining adequate images based on body habitus.

Keywords
Ultrasound, Emergency Medicine, Abdominal Wall, Muscle Layers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06955013
Study groupRoleWhat they receive
Healthy volunteer; BMI 29.9 and belowNot described
Healthy volunteer; BMI 30 and aboveNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates of success in obtaining adequate images

    Measured: Up to one week after ultrasound

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2025
  2. Study start25 Aug 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06955013
Sponsor's protocol ID
CHLIRB#1659
Status last verified
Dec 2025
First submitted
24 Apr 2025
Last updated
17 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by Corewell Health South 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amanda L Borchardt (920-342-5023, amanda.borchardt@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of success in obtaining adequate images (time frame: Up to one week after ultrasound). 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 17 Dec 2025.

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