Trial Outcomes & Findings for Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain (NCT NCT05803096)

NCT ID: NCT05803096

Last Updated: 2024-01-30

Results Overview

Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 143 participants
• Primary outcome timeframe: 5-minutes after prostate biopsy
• Results posted on: 2024-01-30

Participant Flow

Of note, 143 patients were consented for procedure, but only 133 were randomized. This discrepancy was due to study staff availability or patient cancellation of procedure.

Participant milestones

Measure	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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Overall Study STARTED	66	67
Overall Study COMPLETED	61	67
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.	Total n=128 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 11.5 • n=5 Participants	65.8 years STANDARD_DEVIATION 7.8 • n=7 Participants	65.2 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	67 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized White	50 participants n=5 Participants	56 participants n=7 Participants	106 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	61 Participants n=5 Participants	67 Participants n=7 Participants	128 Participants n=5 Participants
History of Prostate Cancer Prior to Enrollment	26 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants
Past Medical History of Depression	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Past Medical History of Anxiety	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Pre-Biopsy VAS-Anxiety	3 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants
Pre-Biopsy VAS-Pain	0 units on a scale n=5 Participants	0 units on a scale n=7 Participants	0 units on a scale n=5 Participants
Pre-Biopsy STAI	12 units on a scale n=5 Participants	12 units on a scale n=7 Participants	12 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 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])

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Post-biopsy Pain (VAS-P)	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: 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])

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Post-biopsy Anxiety (VAS-A)	0 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Post-biopsy Anxiety Traits (STAI)	11 score on a scale Interval 7.0 to 14.0	12 score on a scale Interval 9.0 to 14.0

SECONDARY outcome

Timeframe: Length of prostate biopsy; up to 30 minutes

Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Time of Prostate Biopsy	10.6 minutes Interval 9.0 to 12.6	10.3 minutes Interval 8.5 to 11.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Operator Assessment of "Tolerating Insertion of Rectal Probe"	2 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Operator Assessment of "Patient Maintenance of Positioning"	2 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Self-Administered Nitrous Oxide n=61 Participants 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 Participants Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
Operator Assessment of "Patient Tolerance of Procedure"	2 score on a scale Interval 2.0 to 3.0	2 score on a scale Interval 2.0 to 3.0

Adverse Events

Self-Administered Nitrous Oxide

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Oxygen

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Self-Administered Nitrous Oxide n=61 participants at risk 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.	Oxygen n=67 participants at risk Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
General disorders Facial Flushing	1.6% 1/61 • Number of events 1 • 30 days	0.00% 0/67 • 30 days
Renal and urinary disorders Urinary Retention	0.00% 0/61 • 30 days	1.5% 1/67 • Number of events 1 • 30 days
Hepatobiliary disorders Acute Cholangitis	0.00% 0/61 • 30 days	1.5% 1/67 • Number of events 1 • 30 days

Additional Information

Dr. Heidi Rayala

Beth Israel Medical Center

Phone: 16176673739

Email: hrayala@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place