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

NCT05819801 | Recruiting

• 1 other identifier: #2157
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Amsterdam Preoperative Anxiety and Information Score

  Measure of anxiety

  Prior to and immediately following the procedure

Secondary Outcomes (8)

• Heart rate

  Prior to and immediately following the procedure

• Blood pressure

  Prior to and immediately following the procedure

• Hunger scale

  Prior to and immediately following the procedure

• Thirst scale

  Prior to and immediately following the procedure

• Nausea scale

  Prior to and immediately following the procedure

Study Arms (2)

Fasting

ACTIVE COMPARATOR

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

Not Fasting

EXPERIMENTAL

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

Fasting OTHER

Instructing patients to fast before their local-only procedure

Fasting

Non-fasting OTHER

Instructing patients to eat before their local-only procedure

Not Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Health Manchester Pavilion

Orange, California, 92868, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 36420465 BACKGROUND

• 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.

  PMID: 36425368 BACKGROUND

• 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.

  PMID: 35919690 BACKGROUND

• 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.

  PMID: 35919552 BACKGROUND

• 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.

  PMID: 28045707 BACKGROUND

• 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.

  PMID: 19190563 BACKGROUND

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Jesse Kaplan, MD

  UCI School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael W Madsen, BA

CONTACT

2083090808; mwmadsen@hs.uci.edu

Mikhail Pakvasa, MD

CONTACT

714.456.5253; mpakvasa@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Patients will be randomly divided into two groups and told whether to eat or fast prior to their procedure

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: February 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)