Procedural Pain Clinical Trial
— SANO-VASOfficial title:
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
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.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | November 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Scheduled for vasectomy 2. Aged 21 to 85 years 3. Suitable for receipt of inhaled nitrous oxide/oxygen 4. Access to an email and computer Exclusion Criteria: 1. Perioral facial hair impeding good mask seal 2. Cognitive impairment that impedes ability to complete survey questions 3. Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy 4. Has any of the following medical conditions, which contraindicate use of nitrous oxide: 1. Inner ear, bariatric or eye surgery within the last 2 weeks, 2. Current emphysematous blebs, 3. Severe B-12 deficiency, 4. Bleomycin chemotherapy within the past year, 5. Heart attack within the past year, 6. Stroke within the past year, 7. Class III or higher heart failure. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 immediately after completion of vasectomy | |
Secondary | 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 immediately prior to vasectomy | |
Secondary | 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 immediately prior to vasectomy | |
Secondary | 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 immediately after completion of vasectomy | |
Secondary | 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 two weeks and three months after vasectomy | |
Secondary | 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 two weeks and three months after vasectomy | |
Secondary | 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 during and two weeks after vasectomy | |
Secondary | 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 immediately after urologist finishes vasectomy | |
Secondary | 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 during and up to 30 days after day of vasectomy |
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