Recruiting

Fasting

Sponsor:

UCLA

Code:

NCT05819801

Conditions

Surgery

Anesthesia, Local

Fasting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-fasting

Fasting

Study Details

Brief summary:

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.

Conditions

Surgery

Anesthesia, Local

Fasting

Study ID

NCT05819801

Start date

Feb 22, 2024

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing wide-awake, local anesthetic-only, no-tourniquet (WALANT) procedures with the lead researcher.

Exclusion Criteria:

  • Patients with insulin-dependent diabetes or allergy to local anesthesia, < 18 years of age, patients unable to follow up.

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Non-fasting

Instructing patients to eat before their local-only procedure

Fasting

Instructing patients to fast before their local-only procedure

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael W Madsen, BA

2083090808mwmadsen@hs.uci.edu

Mikhail Pakvasa, MD

714.456.5253mpakvasa@hs.uci.edu

Locations

UCI Health Manchester Pavilion

Recruiting

Orange, California, United States, 92868

Contacts

Michael W Madsen, BA

2083090808mwmadsen@hs.uci.edu

Mikhail Pakvasa, MD

(714) 456-7012mpakvasa@hs.uci.edu

Principal Investigator:

Jesse Kaplan, MD

More Information

Sponsor

University of California, Irvine

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-03-12.