Procedural PainPhase 4SANO-VASNCT05895383
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
A Phase 4 study testing Nitrous oxide in people with Procedural Pain and Pain Catastrophizing, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. Read more about this study
- Who is it for?
- Ages 21 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Pain Catastrophizing, Procedural Anxiety
- What is being tested?
- Nitrous oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 30 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
Who cannot join
- Perioral facial hair impeding good mask seal
- Cognitive impairment that impedes ability to complete survey questions
- Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- Has any of the following medical conditions, which contraindicate use of nitrous oxide:
- Inner ear, bariatric or eye surgery within the last 2 weeks,
- Current emphysematous blebs,
Show all 11Show fewer
- Severe B-12 deficiency,
- Bleomycin chemotherapy within the past year,
- Heart attack within the past year,
- Stroke within the past year,
- Class III or higher heart failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michelle Shabo, MD contact
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Peter Healy, phealy1@bidmc.harvard.edu
About this study
This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.
Read the detailed description
Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.
Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.
- Conditions
- Procedural Pain, Pain Catastrophizing, Procedural Anxiety
- Being tested
- Nitrous oxide
- Keywords
- vasectomy, nitrous oxide, experience of care, ambulatory
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxideDrug
Also called Self-adjusted nitrous oxide
Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.
| Study group | Role | What they receive |
|---|---|---|
| Self-adjusted nitrous oxide (SANO) | Experimental | All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy. Receives: Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
Level of pain experienced during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Measured: Measured immediately after completion of vasectomy
Secondary outcomes (8)
Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)
Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Measured: Measured immediately prior to vasectomy
Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Measured: Measured immediately prior to vasectomy
Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Level of anxiety experienced during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Measured: Measured immediately after completion of vasectomy
Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)
Level of pain recalled during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Measured: Measured two weeks and three months after vasectomy
Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)
Level of anxiety recalled during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Measured: Measured two weeks and three months after vasectomy
Satisfaction assessed by Likert scale
Satisfaction of concentration of SANO during vasectomy will be measured by the maximum concentration of SANO reached during the procedure compared to participants' response to: "How do you feel about the level of SANO you received during the vasectomy?" (less than I would like, about right, more than I would like) and "How helpful do you think SANO was in relieving your pain and anxiety?" (very helpful, unhelpful, undecided, helpful very helpful).
Measured: Measured during and two weeks after vasectomy
Operator ease of performing vasectomy
Operating urologist will be asked to fill out a three-item "operator survey" that asks if "Patient tolerated lidocaine injection," "Patient maintained positioning," and "Patient tolerated vasectomy," "Worse than expected (-1)", "As expected (0)" or "Better than expected (+1)." The composite score will be used as a measure of operator ease.
Measured: Measured immediately after urologist finishes vasectomy
Emergent adverse events as assessed by frequency of incidents
Emergent adverse events possibly related to SANO will be recorded by frequency on the day-of the vasectomy and by monitoring participants' online medical record up to 30 days after the vasectomy. Termination of SANO during the vasectomy due to discomfort, nausea, or vomiting will also be considered as adverse events related to SANO.
Measured: Measured during and up to 30 days after day of vasectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start24 May 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive nitrous oxide at levels of mild sedation during vasectomy. Participants will hold a remote control to adjust the level of gas administered according to their comfort level.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Rayala, Beth Israel Deaconess Medical Center
- Investigators
- Heidi Rayala, MD, PhD, Principal investigator, Beth Israel Deaconess Medical CenterMarissa Kent, MD, Study chair, Beth Israel Deaconess Medical CenterPeter Steinberg, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895383
- Sponsor's protocol ID
- 2023P-000328
- Acronym
- SANO-VAS
- Status last verified
- Feb 2026
- First submitted
- 31 May 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
- ClinicalTrials.gov ID
- NCT05895383
- Acronym / sponsor ID
- SANO-VAS / 2023P-000328
- Conditions
- Procedural Pain, Pain Catastrophizing, Procedural Anxiety
- Keywords
- vasectomy, nitrous oxide, experience of care, ambulatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.
Detailed description
Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.
Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive nitrous oxide at levels of mild sedation during vasectomy. Participants will hold a remote control to adjust the level of gas administered according to their comfort level.
| Arm | Type | Receives |
|---|---|---|
| Self-adjusted nitrous oxide (SANO) | Experimental | Drug: Nitrous oxideAll patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
Key exclusion criteria (11 listed)
- Perioral facial hair impeding good mask seal
- Cognitive impairment that impedes ability to complete survey questions
- Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- Has any of the following medical conditions, which contraindicate use of nitrous oxide:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous oxideAlso: Self-adjusted nitrous oxideNitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control. | Drug | Self-adjusted nitrous oxide (SANO) |
Primary outcome
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
Time frame: Measured immediately after completion of vasectomy
Level of pain experienced during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
8 secondary outcomes
Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)
Time frame: Measured immediately prior to vasectomy
Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Time frame: Measured immediately prior to vasectomy
Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Time frame: Measured immediately after completion of vasectomy
Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)
Time frame: Measured two weeks and three months after vasectomy
Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)
Time frame: Measured two weeks and three months after vasectomy
Satisfaction assessed by Likert scale
Time frame: Measured during and two weeks after vasectomy
Operator ease of performing vasectomy
Time frame: Measured immediately after urologist finishes vasectomy
Emergent adverse events as assessed by frequency of incidents
Time frame: Measured during and up to 30 days after day of vasectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Shabo, MD contact
Heidi Rayala, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
Marissa Kent, MD study chair
Beth Israel Deaconess Medical Center
Peter Steinberg, MD study chair
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrous oxide in people with Procedural Pain and Pain Catastrophizing, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Rayala, MD, PhD (617-667-3739, hrayala@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P) (time frame: Measured immediately after completion of vasectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.