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Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy (SANO-VAS)

Primary Purpose

Procedural Pain, Pain Catastrophizing, Procedural Anxiety

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitrous oxide
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Pain focused on measuring vasectomy, nitrous oxide, experience of care, ambulatory

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Scheduled for vasectomy Aged 21 to 85 years Suitable for receipt of inhaled nitrous oxide/oxygen Access to an email and computer Exclusion Criteria: 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, 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.

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-adjusted nitrous oxide (SANO)

Arm Description

All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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.
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.

Full Information

First Posted
May 31, 2023
Last Updated
June 13, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05895383
Brief Title
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Acronym
SANO-VAS
Official Title
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Pain Catastrophizing, Procedural Anxiety
Keywords
vasectomy, nitrous oxide, experience of care, ambulatory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-adjusted nitrous oxide (SANO)
Arm Type
Experimental
Arm Description
All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.
Intervention Type
Drug
Intervention Name(s)
Nitrous oxide
Other Intervention Name(s)
Self-adjusted nitrous oxide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
Description
Level of pain experienced during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Time Frame
Measured immediately after completion of vasectomy
Secondary Outcome Measure Information:
Title
Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)
Description
Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Time Frame
Measured immediately prior to vasectomy
Title
Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Description
Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Time Frame
Measured immediately prior to vasectomy
Title
Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Description
Level of anxiety experienced during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Time Frame
Measured immediately after completion of vasectomy
Title
Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)
Description
Level of pain recalled during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).
Time Frame
Measured two weeks and three months after vasectomy
Title
Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)
Description
Level of anxiety recalled during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).
Time Frame
Measured two weeks and three months after vasectomy
Title
Satisfaction assessed by Likert scale
Description
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).
Time Frame
Measured during and two weeks after vasectomy
Title
Operator ease of performing vasectomy
Description
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.
Time Frame
Measured immediately after urologist finishes vasectomy
Title
Emergent adverse events as assessed by frequency of incidents
Description
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.
Time Frame
Measured during and up to 30 days after day of vasectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Scheduled for vasectomy Aged 21 to 85 years Suitable for receipt of inhaled nitrous oxide/oxygen Access to an email and computer Exclusion Criteria: 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Rayala, MD, PhD
Phone
617-667-3739
Email
hrayala@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Shabo, MD
Email
mshabo@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Rayala, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marissa Kent, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Steinberg, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Healy
Email
phealy1@bidmc.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

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