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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-fasting

    Other intervention

    Instructing patients to eat before their local-only procedure

  • Fasting

    Other intervention

    Instructing patients to fast before their local-only procedure

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: FastingActive comparator 1 intervention
Group B: Not FastingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Amsterdam Preoperative Anxiety and Information Score

Measure of anxiety

Time frame
Prior to and immediately following the procedure

Secondary outcomes

1

Heart rate

Measure of heart rate

Time frame
Prior to and immediately following the procedure
2

Blood pressure

Measure of blood pressure

Time frame
Prior to and immediately following the procedure
3

Hunger scale

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

Time frame
Prior to and immediately following the procedure
4

Thirst scale

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

Time frame
Prior to and immediately following the procedure

Other outcomes

Sponsors and contacts

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