Nitrous Oxide for Vasectomy

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Alexandra J. Berger Eberhardt, MD

Must not be taking: Benzodiazepines, Narcotics

Disqualifiers: Anatomy issues, Recent surgeries, Heart failure, others

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether nitrous oxide, a gas commonly used for pain relief, can safely and effectively reduce anxiety and pain during clinic-based vasectomy procedures. Participants will use either self-adjusted nitrous oxide or a placebo (oxygen) to determine its effect on comfort and the overall experience for both patients and doctors. Men planning to have a vasectomy, who can understand and complete questionnaires, and who are willing to participate may be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how nitrous oxide works in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

If you are taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that self-administered nitrous oxide is likely to be safe for use during vasectomies?

Research has shown that self-administered nitrous oxide, in amounts between 20% to 45%, is generally safe in medical settings. For instance, studies found it safe during procedures like prostate biopsies. Patients in these studies did not experience major side effects, and the treatment was considered a safe option.

Although this trial is in an early phase focusing on safety, the previous use of nitrous oxide in similar medical situations provides some reassurance about its safety. However, results can vary, and this trial will gather more specific information about its use during vasectomies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for vasectomy pain management, which typically involves local anesthesia or oral pain medications, this trial explores the use of self-administered nitrous oxide. Researchers are excited about this approach because it introduces a new method of pain relief that can be controlled by the patient, potentially enhancing comfort and reducing anxiety during the procedure. Nitrous oxide acts quickly and wears off rapidly, which could lead to a smoother recovery process compared to traditional options. This innovative approach could offer patients more autonomy and a less invasive experience during vasectomies.

What evidence suggests that self-administered nitrous oxide is effective for reducing anxiety and pain during vasectomy?

This trial will compare the effects of self-administered nitrous oxide with a placebo (oxygen) during vasectomy procedures. Studies have shown that nitrous oxide, or "laughing gas," can reduce pain and anxiety during medical procedures. Research indicates that patients increasingly use a low dose of nitrous oxide for its calming effects during minor surgeries. It helps patients feel more relaxed and eases the experience of care. Previous patients reported feeling less anxious and uncomfortable when using nitrous oxide during procedures. While more research is needed, these early findings suggest it could make vasectomies less stressful. ^{1 4 5 6 7}

Who Is on the Research Team?

Alexandra J Berger Eberheardt, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for men undergoing vasectomy in a clinic setting who are interested in managing their procedure-related anxiety and pain. Specific eligibility criteria details were not provided, so participants should inquire about any additional requirements.

Inclusion Criteria

I am between 18 and 85 years old.

I want a vasectomy for birth control.

Able to understand and complete patient questionnaires

Exclusion Criteria

I prefer not to have a vasectomy in an office and want anesthesia.

I have one missing vas deferens.

My surgeon says I can't have the procedure done in their office due to my anatomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Procedure

Participants complete surveys and assessments immediately prior to the vasectomy procedure

Day of procedure

1 visit (in-person)

Intra-Procedure

Participants receive self-administered nitrous oxide or placebo during the vasectomy procedure; anxiety and pain are assessed

During procedure

1 visit (in-person)

Post-Procedure

Participants complete surveys to assess pain, anxiety, and procedure tolerance after the vasectomy

10 minutes after procedure

1 visit (in-person)

Follow-up

Participants are monitored for complications and adverse events for 30 days after the vasectomy

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Self-Adjusted Nitrous

Trial Overview The study tests if self-administered nitrous oxide (laughing gas) can help reduce anxiety and pain during vasectomies compared to placebo (oxygen). Participants will use the gas themselves at low doses and fill out surveys before, during, and after the procedure.

How Is the Trial Designed?

Group I: Nitrous Oxide Experimental Treatment 1 Intervention

Self-Administered Nitrous Oxide

Group II: Placebo (Oxygen) Placebo Group 1 Intervention

Self-Administered Placebo (Oxygen)

Who Is Running the Clinical Trial?

Alexandra J. Berger Eberhardt, MD

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07245628?aggFilters=status%3A%2Cphase%3A

A Trial of Self-Adjusted Nitrous Versus Placebo During ... 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- ...

2. bwh.trialstoday.org bwh.trialstoday.org/trial/NCT07245628

A Trial of Self-Adjusted Nitrous Versus Placebo During ... 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- ...

3. alicantobidmc.org alicantobidmc.org/index.php/resources/self-adjusted-nitrous-oxide-feasibility-study-setting-vasectomy

Self-Adjusted Nitrous Oxide: A Feasibility Study in ... Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months ...

4. bwh.trialstoday.org bwh.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMDG3tDAxs1TS0bWEAR1jPUMjAwMDcx1DM3NzMyMLCwMQ0FHKSy4xMDQ3tTAwMVKKBQBIrA_q

Search Clinical Trials 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.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37984067/

Practical Use of Self-Adjusted Nitrous Oxide During ... - PubMed Low-dose, adjustable nitrous oxide is increasingly being used to improve experience of care for patients undergoing painful procedures. This ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05895383?cond=Vasectomy&aggFilters=status:not%20rec%20ava&viewType=Table&rank=3

Self-Adjusted Nitrous Oxide: A Feasibility Study in ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

7. trialx.com trialx.com/clinical-trials/listings/235472/self-adjusted-nitrous-oxide-a-feasibility-study-in-the-setting-of-vasectomy/

Self-Adjusted Nitrous Oxide: A Feasibility Study in the ... This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better ...