Effect of Fasting on Patient Outcomes After Wide-Awake, Local Anesthesia-only, No Tourniquet (WALANT) Procedures

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT05819801
Status
Recruiting
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Conditions

  • Anesthesia, Local
  • Fasting
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-fasting — OTHER
    Instructing patients to eat before their local-only procedure
  • Fasting — OTHER
    Instructing patients to fast before their local-only procedure

Study Details

The purpose of this study is to determine whether eating solid food prior to undergoing a wide awake local-only no tourniquet (WALANT) procedure reduces anxiety in patients or has any effect on outcomes. Patients will be split randomly into two groups and told whether to eat or fast before their procedure. We will then compare levels of anxiety and nausea on the day of the procedure as well as satisfaction with the procedure and other outcome measures at follow-up visits. Our hypothesis is that patients who are instructed to eat before their WALANT procedure will have less anxiety, nausea, and overall higher satisfaction compared to those who are instructed to fast prior to their procedure.

Key Dates

Start date
Feb 22, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fasting
    Patients in the fasting group will be told to avoid any food past midnight the day before their surgery and any liquids 4 hours before their scheduled surgery.
  • Experimental: Not Fasting
    The eating group will be told specifically to eat a light meal (equivalent to two slices of toasted bread with butter and jam and one cup of coffee or juice) the morning of their surgery, within two hours of their procedure start time.

Primary Outcome Measure

Amsterdam Preoperative Anxiety and Information Score [ Time Frame: Prior to and immediately following the procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCI Health Manchester PavilionOrangeCalifornia92868
Michael W Madsen, BA
[email protected]
2083090808
Mikhail Pakvasa, MD
[email protected]
(714) 456-7012
Jesse Kaplan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UCI Health Manchester Pavilion· Orange, CA

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