A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy

Early Phase 1RecruitingNCT07245628

Alexandra J. Berger Eberhardt, MD50 enrolled

Overview

The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting. This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy. The main questions it aims to answer are: * Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy. * To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure. Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Vasectomy

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - 85 at the time of screening * Desiring vasectomy for family planning purposes * Able to understand and complete patient questionnaires * Willing and able to provide written consent to participate in the study Exclusion Criteria: * Patients with unilateral absence of the vas deferens * Patients who are deemed by study surgeons to have anatomy no amendable for office procedure * Patients who decline office vasectomy and request monitored anesthesia care * Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure * Patients with contraindications to nitrous oxide including: * Inner ear, bariatric, or eye surgery within the past 2 weeks * Current emphysematous blebs * Severe B-12 deficiency * History of bleomycin chemotherapy within the last year * Class III or higher heart failure

Outcomes

Primary Outcomes

Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

Measuring the mean difference in Visual Analog Scale for Anxiety (VAS-A) during the vasectomy procedure and the Situational Pain Catastrophizing Scale (S-PCS) immediately after the vasectomy procedure, comparing those receiving and not receiving self-administered low dose nitrous oxide. Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety) Intra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety) Post-Procedure (10 Minutes After Procedure Completion, to Allow for Nitrous Oxide to be Metabolized) 1. Situational Pain Catastrophizing Scale (S-PCS) (Zero is equivalent to not at all and 4 indicates all the time) 2. Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)

Time frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)

Secondary Outcomes

Mean Difference in Visual Analog Scale for Pain (VAS-P) Intra-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain) Intra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)

Time frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Intra-Procedure (In Between Left and Right Sides of Procedure)

Mean Difference in VAS-P and STAI Pre- and Post-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

Pre-Procedure (Day of Procedure, Immediately Prior) 1. Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain) 2. State Trait Anxiety Inventory (STAI) (1 is equivalent to not at all and 4 indicates very much) Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized) 1. Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain) 2. State Trait Anxiety Inventory (STAI) (1 is equivalent to not at all and 4 indicates very much)

Time frame: Pre-Procedure (Day of Procedure, Immediately Prior) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)

Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

Measured using the The Common Terminology Criteria for Adverse Events (CTCAE) grading scale (v5.0). CTCAE v5.0 (1 is equivalent to mild and 5 indicates death related to AE)

Time frame: Study Enrollment - 30 Days After Vasectomy

Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

Post-Procedure, Day of Vasectomy Ease of Procedure (1 is equivalent to the urologist determining the procedure went worse than expected and 3 indicates the urologist determines the procedure went better than expected)

Time frame: Post-Procedure, Day of Vasectomy

Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

Patient Tolerance (1 is equivalent to the urologist determining the patient's tolerance for the procedure was worse than expected and 3 indicates the urologist determines the patient's tolerance for the procedure was better than expected)