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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Surgery; Fasting
• Intervention / Treatment: Other: Fasting; Other: Non-fasting

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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael W Madsen, BA; Phone Number: 2083090808; Email: mwmadsen@hs.uci.edu
• Study Contact Backup: Name: Mikhail Pakvasa, MD; Phone Number: 714.456.5253; Email: mpakvasa@hs.uci.edu

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • UCI Health Manchester Pavilion
      • Contact: Michael W Madsen, BA; Phone Number: 2083090808; Email: mwmadsen@hs.uci.edu
      • Contact: Mikhail Pakvasa, MD; Phone Number: (714) 456-7012; Email: mpakvasa@hs.uci.edu
      • Principal Investigator: Jesse Kaplan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Instructing patients to fast before their local-only procedure
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; Instructing patients to eat before their local-only procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amsterdam Preoperative Anxiety and Information Score	Measure of anxiety	Prior to and immediately following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Measure of heart rate	Prior to and immediately following the procedure
Blood pressure	Measure of blood pressure	Prior to and immediately following the procedure
Surgical Satisfaction - 8 Score	Measure of satisfaction with the procedure	Approximately 2 weeks after the procedure
QuickDASH Score	Measure of functional status of the upper extremity	Approximately 6 weeks after the procedure
Hunger scale	Visual analog scale of hunger (0-10, 10 being more hunger)	Prior to and immediately following the procedure
Thirst scale	Visual analog scale of thirst (0-10, 10 being more thirst)	Prior to and immediately following the procedure
Nausea scale	Visual analog scale of nausea (0-10, 10 being more nausea)	Prior to and immediately following the procedure
Pain scale	Visual analog scale of pain (0-10, 10 being more pain)	Prior to and immediately following the procedure

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Jesse Kaplan, MD, UCI School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Fasting; Angptl4 protein, mouse
• Other Study ID Numbers: #2157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No