Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

Study Overview
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Brief Summary
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Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.

Detailed Description
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Nitrous oxide is a well-tolerated inhaled anesthetic that has been used for decades in pediatric and adult populations and is largely viewed as effective and safe. In addition to analgesic effect, nitrous oxide also produces a dissociative euphoria and amnesia that could potentially improve patients' anxiety and experience of cancer care. When used as a single agent at concentrations ≤50%, the American Society of Anesthesiologists (ASA) classifies nitrous oxide as Minimal Sedation, producing a state in which a patient responds normally to verbal commands, maintains airway reflexes, and spontaneous ventilation. Over the past several decades nitrous oxide has become less common due to concerns of nitrous oxide environmental exposure to the care team. There are now Federal Drug Administration (FDA)-approved systems that allow patient self-administered nitrous oxide (SANO), and importantly, include a scavenger system to eliminate exhaled environmental nitrous oxide. These systems are rapidly being adopted throughout the United States in Urology practices, but to date, there have been no studies evaluating patient outcomes and possible risks with the adjunct use of SANO. This study is a prospective, randomized, controlled trial to assess patient perceived pain and anxiety related to prostate needle biopsy with or without SANO, and the frequency of complications associated with SANO. A secondary aim will be to demonstrate that the SANO at the time of prostate biopsy does not significantly increase burden on Urologist productivity, nor increase the difficulty of operator ease in performing the prostate needle biopsy.

Official Title
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Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

Conditions
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Prostate Disease, Malignancy, Benign Prostatic Hyperplasia, Prostate Cancer, Prostate Adenocarcinoma, Anxiety and Fear, Pain

Intervention / Treatment
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* Drug: Self-Administered Nitrous Oxide
* Other: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biological male Aged 18 to 85 years Scheduled for clinically-indicated prostate needle biopsy Suitable for nitrous oxide/oxygen with willingness to be randomized to inhaled SANO or inhaled oxygen during the procedure Access to an email and computer Exclusion Criteria: Perioral facial hair impeding good mask seal Learning disabilities and/or inability to cognitively complete survey questions Taken a pre-procedure benzodiazepine or narcotic. Has any of the following medical conditions: Inner ear, bariatric or eye surgery within the last 2 weeks, Current emphysematous blebs, Severe B-12 deficiency. Bleomycin chemotherapy within the past year. Class III or higher heart failure. Undergoing novel therapy for prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized 1:1 to either SANO (treatment) or oxygen (placebo control) after completion of baseline assessment. The results of the randomization will not be disclosed to patients as part of the study (patient-blinded).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Administered Nitrous Oxide<br>Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy. After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question are you feeling the nitrous and are you happy at this level. The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position. | Drug: Self-Administered Nitrous Oxide<br>* Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.<br>* Other names: nitrous oxide;|
| Placebo Comparator: Oxygen<br>Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. | Other: Oxygen<br>* Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-biopsy pain (VAS-P) | Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 [no pain] - 10 [worst pain]) | 5-minutes after prostate biopsy | 
| Post-biopsy anxiety (VAS-A) | Anxiety experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 [no anxiety] - 10 [worst anxiety]) | 5-minutes after prostate biopsy | 
| Post-biopsy anxiety traits (STAI) | Anxious traits exhibited after prostate biopsy as measured by the State Trait Anxiety Inventory (STAI) (range: 6-36; 36 being 'worst' anxiety). | 5-minutes after prostate biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of prostate biopsy | Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy | Length of prostate biopsy; up to 30 minutes | 
| Operator ease of performing procedure | Operating urologist will be asked to fill out a three-item operator survey that asks if Insertion of rectal probe, patient maintenance of positioning, and patient tolerance of procedure, was worse than expected (-1), as expected (0) or better than expected (+1) the composite score will be compared between groups | Immediately after prostate biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate biopsy, nitrous oxide, prostate cancer, ambulatory, patient experience of care