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

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients will initially present for preoperative evaluation in clinic, where informed consent will be obtained prior to them being enrolled in the study. 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. 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. 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. 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. 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. 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.

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

Conditions
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Anesthesia, Local, Fasting, Surgery

Intervention / Treatment
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* Other: Non-fasting
* Other: Fasting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fasting<br>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<br>* Instructing patients to fast before their local-only procedure<br>|
| Experimental: Not Fasting<br>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<br>* Instructing patients to eat before their local-only procedure<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 |