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RecruitingNCT05819801Updated Mar 12, 2026

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

An interventional study of Non-fasting and Fasting in Surgery, Anesthesia, Local and Fasting, sponsored by University of California, Irvine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description
  • Patients will initially present for preoperative evaluation in clinic, where they will be approached about whether they are interested in participating. More thorough discussion about risks and benefits will either take place in person at this visit, or over the phone. Consent forms will be signed in person or via Qualtrics/RedCap. If they choose to participate, they will be assigned either to the eating group or the fasting group. 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. 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. Preoperatively demographic information will be collected via paper forms or via Qualtrics/RedCap both via interview and from medical records, and a pre-operative QuickDASH will be collected as well. All their other preoperative instructions will be consistent with the current protocols.
  • On their day of surgery, they will present to the hospital at the pre-arranged time. They will be taken to the preoperative area, where they will be treated in the standard way to prepare them for any procedure. While in the preoperative area, they will be asked whether they ate solid food prior to arrival. They will also be assessed using the Amsterdam Preoperative Anxiety and Information Score and preoperative pain/nausea visual analog score either on paper forms or via Qualtrics/RedCap. Heart rate, blood pressure, and body mass index will also be collected. They will then undergo their procedure the same way regardless of whether they ate.
  • Postoperatively, they will be taken to the recovery room. There, they will again be assessed using the Amsterdam Preoperative Anxiety and Information Score and postoperative pain/nausea visual analog score either on paper forms or via Qualtrics/RedCap. Heart rate and blood pressure will also be collected at this time.
  • Patients will be followed at regular intervals following their procedure at 2 weeks and 6 weeks. At their first postoperative visit, patients will be assessed using the surgical satisfaction-8 scores either on paper forms or via Qualtrics/RedCap.
  • Patients will also be given the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) to complete at their second postoperative visit at approximately 6 weeks either on paper forms or via Qualtrics/RedCap.
  • Patient data will be collected until 6 months post operatively. Complications such as wound healing, infections, medication side effects will be included in data collection, these will be collected from medical records only and no further study surveys or interventions will be performed after the second postoperative visit.
02

Conditions studied

  • Surgery
  • Anesthesia, Local
  • Fasting

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03

In context

Fasting

392 studies on the registry are indexed under Fasting; 63 are open to participants now.

This study's planned enrollment of 134 is above the median of 45 across 311 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Browse University of California, Irvine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with insulin-dependent diabetes or allergy to local anesthesia, \< 18 years of age, patients unable to follow up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (estimated)

Study 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.

    Other: Fasting

  • 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.

    Other: Non-fasting

Interventions

  • OtherNon-fasting

    Instructing patients to eat before their local-only procedure

  • OtherFasting

    Instructing patients to fast before their local-only procedure

06

What researchers measure

Primary outcomes

  1. Amsterdam Preoperative Anxiety and Information Score

    Measure of anxiety

    Time frame: Prior to and immediately following the procedure

Secondary outcomes

  1. Heart rate

    Measure of heart rate

    Time frame: Prior to and immediately following the procedure

  2. Blood pressure

    Measure of blood pressure

    Time frame: Prior to and immediately following the procedure

  3. Hunger scale

    Visual analog scale of hunger (0-10, 10 being more hunger)

    Time frame: Prior to and immediately following the procedure

  4. Thirst scale

    Visual analog scale of thirst (0-10, 10 being more thirst)

    Time frame: Prior to and immediately following the procedure

  5. Nausea scale

    Visual analog scale of nausea (0-10, 10 being more nausea)

    Time frame: Prior to and immediately following the procedure

  6. Pain scale

    Visual analog scale of pain (0-10, 10 being more pain)

    Time frame: Prior to and immediately following the procedure

  7. Surgical Satisfaction - 8 Score

    Measure of satisfaction with the procedure

    Time frame: Approximately 2 weeks after the procedure

  8. QuickDASH Score

    Measure of functional status of the upper extremity

    Time frame: Approximately 6 weeks after the procedure

07

Study locations

1 of 1 sites recruiting
  • UCI Health Manchester Pavilion
    Orange, California 92868, United States
    Recruiting
08

References and documents

Publications

  • Connors KM, Guerra SM, Koehler SM. Current Evidence Involving WALANT Surgery. J Hand Surg Glob Online. 2022 Mar 1;4(6):452-455. doi: 10.1016/j.jhsg.2022.01.009. eCollection 2022 Nov. PubMed 36420465 ↗
  • Shou Wai AT, Abdullah S, Ahmad AA, Yong LC, Jabar FA, Ahmad AR. Prospective Evaluation of Pain and Anxiety Levels Between Wide-Awake Local Anesthesia No Tourniquet and General Anesthesia With Tourniquet in Excision of Wrist Ganglions. J Hand Surg Glob Online. 2022 Aug 5;4(6):414-420. doi: 10.1016/j.jhsg.2022.07.002. eCollection 2022 Nov. PubMed 36425368 ↗
  • Miller MB, Gabel SA, Gluf-Magar LC, Haan PS, Lin JC, Clarkson JHW. Virtual Reality Improves Patient Experience and Anxiety During In-office Carpal Tunnel Release. Plast Reconstr Surg Glob Open. 2022 Jul 13;10(7):e4426. doi: 10.1097/GOX.0000000000004426. eCollection 2022 Jul. PubMed 35919690 ↗
  • Shahid S, Saghir N, Saghir R, Young-Sing Q, Miranda BH. WALANT: A Discussion of Indications, Impact, and Educational Requirements. Arch Plast Surg. 2022 Jul 30;49(4):531-537. doi: 10.1055/s-0042-1748659. eCollection 2022 Jul. PubMed 35919552 ↗
  • Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available. PubMed 28045707 ↗
  • Bopp C, Hofer S, Klein A, Weigand MA, Martin E, Gust R. A liberal preoperative fasting regimen improves patient comfort and satisfaction with anesthesia care in day-stay minor surgery. Minerva Anestesiol. 2011 Jul;77(7):680-6. Epub 2009 Feb 4. PubMed 19190563 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Jun 2026, 28 months after the start.

Of 144 non-industry interventional studies with no phase under Fasting, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's planned 28 months is above that.

Counting every sponsor, half of 149 studies reached it within 18 months; a quarter within 6 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2023
First posted
Apr 19, 2023
StartActual
Feb 22, 2024
Primary completionEst.
Jun 2026
CompletionEst.
Sep 2026
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05819801
Lead sponsor
University of California, Irvine
Responsible party
Jesse Kaplan (Assistant Clinical Professor, University of California, Irvine) — Principal investigator
First posted
Apr 19, 2023
Start date
Feb 22, 2024
Primary completion
Jun 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Mar 12, 2026

Study contacts

Michael W Madsen, BA
Contact
mwmadsen@hs.uci.edu
2083090808
Mikhail Pakvasa, MD
Contact
mpakvasa@hs.uci.edu
714.456.5253
Jesse Kaplan, MD
principal investigator · UCI School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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