Health TrialsbyHealthPanel

Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures

ConditionHand Injuries and Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarilion Clinic

About this trial

The goal of this clinical trial is to learn whether a standardized preoperative educational video improves expectation management and the patient experience in adults undergoing Wide-Awake Local Anesthesia No Tourniquet (WALANT) hand surgery. The main questions it aims to answer are:

1. Does watching a preoperative educational video help patients better understand what to expect from their WALANT surgical experience? 2. Does watching the video impact anxiety scores, pain scores, overall satisfaction, and patient-reported functional outcomes?

Researchers will compare patients who receive traditional preoperative counseling plus the educational video with patients who receive traditional preoperative counseling alone to determine whether the video improves the patient experience.

Participants will:

* Complete questionnaires about their expectations, anxiety, pain, hand function, and satisfaction before, during, and after their WALANT procedure. * If assigned to the video group, watch a standardized educational video explaining what to expect before, during, and after WALANT surgery. * Complete their final study questionnaires at their 2-week postoperative follow-up visit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years

Scheduled for an elective WALANT procedure with a Carilion Clinic hand surgeon

Able to read and understand English

Capacity to consent

Disqualifiers

Prior WALANT surgery

Visual impairment that would prevent the participant from watching the preoperative educational video

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative WALANT Educational Video

    Behavioral

    A standardized preoperative educational video designed to prepare patients for their WALANT surgical experience. The video provides information about preparation for surgery, administration of the local anesthetic injection, the treatment room environment, sensations patients may experience while awake during surgery, options for interacting with or observing the procedure, postoperative recovery, and other expectations surrounding the WALANT experience.

  • Traditional Preoperative Counseling

    Behavioral

    Standard preoperative counseling provided by the treating physician as part of routine clinical care for patients undergoing WALANT hand surgery.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Traditional Preoperative CounselingActive comparator 1 intervention
Group B: Traditional Preoperative Counseling Plus Educational VideoExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Expectation Management Assessed by Adapted MODEMS

Patient expectation management will be assessed using an adapted version of the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS). Participants complete preoperative MODEMS domains before surgery and corresponding postoperative domains following their WALANT procedure to assess their expectations and experiences.

Time frame
Day of surgery, repeat at 2-week postoperative follow-up visit

Secondary outcomes

1

Anxiety Assessed by Numeric Rating Scale (NRS-A)

Patient-reported anxiety will be assessed using the NRS-Anxiety at enrollment and at specified perioperative time points on the day of surgery. The rating scale will go from 0 = No anxiety, 1 to 3 = Mild anxiety, 4 to 6 = Moderate anxiety, 7 to 10 = Severe anxiety

Time frame
At enrollment phone call, Day of surgery immediately before anesthesia, Day of surgery immediately before first incision
2

Pain Assessed by Numeric Rating Scale (NRS-Pain)

Patient-reported pain will be assessed following administration of the local anesthetic injection and following the first surgical incision. Rating scale scoring: 0 = No pain, 1 to 3 = Mild pain (nagging, annoying, interferes little with daily activities), 4 to 6 = Moderate pain, 7 to 10 = Severe pain

Time frame
Day of surgery
3

Upper Extremity Function Assessed by QuickDASH

Patient-reported upper extremity function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.

Time frame
From enrollment through 2-week postoperative follow-up
4

Overall Patient Satisfaction

Overall satisfaction with the WALANT experience will be assessed using a 5-point Likert scale and a binary satisfaction question

Time frame
2-week postoperative follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carilion Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: