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SurgeryNCT05819801

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

A study testing Non-fasting and Fasting in people with Surgery and Anesthesia, Local, run by University of California, Irvine 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery, Anesthesia, Local, Fasting
What is being tested?
Non-fasting and Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteUnited States
Study dates
22 Feb 2024to Sep 2026
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

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

Michael W Madsen, BA contact

2083090808

mwmadsen@hs.uci.edu

Mikhail Pakvasa, MD contact

714.456.5253

mpakvasa@hs.uci.edu

United States1 site, 1 recruiting

  • UCI Health Manchester Pavilion

    Orange, California, 92868

    Michael W Madsen, BA, 2083090808, mwmadsen@hs.uci.edu

    Mikhail Pakvasa, MD, (714) 456-7012, mpakvasa@hs.uci.edu

    Recruiting

Other trials in United States

About this study

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.
Being tested
Non-fasting, Fasting
Medical subject headings
Fasting

What participants receive

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

  • Non-fastingOther

    Instructing patients to eat before their local-only procedure

  • FastingOther

    Instructing patients to fast before their local-only procedure

Study groups in NCT05819801
Study groupRoleWhat they receive
FastingActive comparatorPatients 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.
Receives: Other: Fasting
Not FastingExperimentalThe 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.
Receives: Other: Non-fasting

What is being measured

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

  1. Amsterdam Preoperative Anxiety and Information Score

    Measure of anxiety

    Measured: Prior to and immediately following the procedure

Secondary outcomes (8)

  1. Heart rate

    Measure of heart rate

    Measured: Prior to and immediately following the procedure

  2. Blood pressure

    Measure of blood pressure

    Measured: Prior to and immediately following the procedure

  3. Hunger scale

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

    Measured: Prior to and immediately following the procedure

  4. Thirst scale

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

    Measured: Prior to and immediately following the procedure

  5. Nausea scale

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

    Measured: Prior to and immediately following the procedure

  6. Pain scale

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

    Measured: Prior to and immediately following the procedure

  7. Surgical Satisfaction - 8 Score

    Measure of satisfaction with the procedure

    Measured: Approximately 2 weeks after the procedure

  8. QuickDASH Score

    Measure of functional status of the upper extremity

    Measured: Approximately 6 weeks after the procedure

Timeline

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

  1. First posted19 Apr 2023
  2. Study start22 Feb 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomly divided into two groups and told whether to eat or fast prior to their procedure
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05819801
Sponsor's protocol ID
#2157
Status last verified
Mar 2026
First submitted
6 Apr 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Non-fasting and Fasting in people with Surgery and Anesthesia, Local, run by University of California, Irvine 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 1 inclusion and 1 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 12 Mar 2026. 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 Michael W Madsen, BA (2083090808, mwmadsen@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amsterdam Preoperative Anxiety and Information Score (time frame: Prior to and immediately following the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05819801, which also lists 6 linked publications.

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 12 Mar 2026.

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