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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:
Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous Oxide | Experimental | Self-Administered Nitrous Oxide |
|
| Placebo (Oxygen) | Placebo Comparator | Self-Administered Placebo (Oxygen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide | Drug | Self-Administered Nitrous Oxide |
| |
| Oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra J Berger Eberheardt, MD | Brigham and Women's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| Drug |
Self-Administered Oxygen |
|
| 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)
Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
| 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) | 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) | 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) | Post-Procedure, Day of Vasectomy |
| 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) |
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |