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Trial Outcomes & Findings for Narcotic-Free Percutaneous Nephrolithotomy (NCT NCT05924165)

NCT ID: NCT05924165

Last Updated: 2025-03-26

Results Overview

Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

post-op day 5 and post-op day 10

Results posted on

2025-03-26

Participant Flow

Participants enrolled from 5-19-2023 to 12-26-2024

Participant milestones

Participant milestones
Measure
Opioid Group
Patients prescribed 5mg Oxycodone, Q6 as needed (PRN) postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Overall Study
STARTED
45
45
Overall Study
COMPLETED
43
42
Overall Study
NOT COMPLETED
2
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Opioid Group
Patients prescribed 5mg Oxycodone, Q6 as needed (PRN) postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Overall Study
Physician Decision
2
3

Baseline Characteristics

Narcotic-Free Percutaneous Nephrolithotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Opioid Group
n=43 Participants
Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
n=42 Participants
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Total
n=85 Participants
Total of all reporting groups
Age, Continuous
65 years
n=5 Participants
63 years
n=7 Participants
64 years
n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
18 Participants
n=7 Participants
36 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
24 Participants
n=7 Participants
49 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants
n=5 Participants
32 Participants
n=7 Participants
64 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
White
26 Participants
n=5 Participants
25 Participants
n=7 Participants
51 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
n=5 Participants
10 Participants
n=7 Participants
20 Participants
n=5 Participants
Body Mass Index (BMI)
27.98 kg/m^2
n=5 Participants
27.42 kg/m^2
n=7 Participants
27.46 kg/m^2
n=5 Participants

PRIMARY outcome

Timeframe: post-op day 5 and post-op day 10

Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates "no pain" and the maximum score of '10' indicates "Worst pain imaginable" along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded

Outcome measures

Outcome measures
Measure
Opioid Group
n=43 Participants
Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
n=42 Participants
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Visual Analog Scale (VAS) Pain Scores
post-op day 5
4.5 score on a scale
Interval 3.0 to 7.0
5 score on a scale
Interval 3.0 to 6.0
Visual Analog Scale (VAS) Pain Scores
post-op day 10
1 score on a scale
Interval 0.0 to 2.0
1 score on a scale
Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: post-op at day 10

A pill count will be conducted of each prescribed postoperative medication.

Outcome measures

Outcome measures
Measure
Opioid Group
n=43 Participants
Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
n=42 Participants
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Pill Count
6.5 pills
Standard Deviation 5
12 pills
Standard Deviation 6

SECONDARY outcome

Timeframe: post-op up to day 10

Number of participants with pain related calls to the office recorded.

Outcome measures

Outcome measures
Measure
Opioid Group
n=43 Participants
Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
n=42 Participants
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Number of Participants Who Called the Office
5 Participants
8 Participants

SECONDARY outcome

Timeframe: post-op up to day 10

Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.

Outcome measures

Outcome measures
Measure
Opioid Group
n=43 Participants
Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
n=42 Participants
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Number of Participants With Pain Related Visits
3 Participants
2 Participants

SECONDARY outcome

Timeframe: post-op at day 10

Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

Outcome measures

Outcome measures
Measure
Opioid Group
n=43 Participants
Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively. 5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain.
NSAID
n=42 Participants
Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively. 10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain.
Patient-related Outcome Survey (PROMIS) Scores
10 T-score
Interval 7.0 to 13.0
10 T-score
Interval 8.0 to 15.0

Adverse Events

Opioid Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

NSAID

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mantu Gupta

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-1272

Results disclosure agreements

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