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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05819801
• Other study ID #: #2157
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Fasting
• Surgery

Intervention

Other:
• Non-fasting
Instructing patients to eat before their local-only procedure
• Fasting
Instructing patients to fast before their local-only procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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