Vasectomy
Conditions
Keywords
Vasectomy, Nitrous Oxide, Men's Health
Brief summary
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.
Interventions
DRUGNitrous Oxide
Self-Administered Nitrous Oxide
DRUGOxygen
Self-Administered Oxygen
Sponsors
Alexandra J. Berger Eberhardt, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized) | 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) |
| Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide | Study Enrollment - 30 Days After Vasectomy | 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) |
| 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) - Intra-Procedure (In Between Left and Right Sides of Procedure) | 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) |
| Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide | Post-Procedure, Day of Vasectomy | 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) |
| Mean Difference in Duration of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide | Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized) | — |
| Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide | Post-Procedure, Day of Vasectomy | 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) |
Countries
United States
Outcome results
None listed