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

Phase 4

Completed

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

Interventions: Drug: Self-Administered Nitrous Oxide
Other: Oxygen

Registration Number: NCT05803096

Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 143

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:
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. Class III or higher heart failure.
6. Undergoing novel therapy for prostate cancer

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Administered Nitrous Oxide	Self-Administered Nitrous Oxide	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.
Oxygen	Oxygen	Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Operator Assessment of "Patient Maintenance of Positioning"	Immediately after prostate biopsy; within 5 minutes after completion of biopsy.	Operating urologist filled out a survey to assess their perception of patient: Patient maintenance of positioning. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).
Time of Prostate Biopsy	Length of prostate biopsy; up to 30 minutes	Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy
Operator Assessment of "Patient Tolerance of Procedure"	Immediately after prostate biopsy; within 5 minutes after completion of biopsy.	Operating urologist filled out a survey to assess their perception of patient: Patient Tolerance of Procedure. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).
Operator Assessment of "Tolerating Insertion of Rectal Probe"	Immediately after prostate biopsy; within 5 minutes after completion of biopsy.	Operating urologist filled out a survey to assess their perception of patient: Tolerating Insertion of rectal probe. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).