Trial Outcomes & Findings for Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones (NCT NCT04597619)

NCT ID: NCT04597619

Last Updated: 2023-09-25

Results Overview

Number of enrolled patients / patients approached

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 year or until subject accrual is complete
• Results posted on: 2023-09-25

Participant Flow

Participant milestones

Measure	Pre-Implementation Cohort Cohort undergoing percutaneous nephrolithotomy (PCNL) prior to implementation of the novel nonopioid pathway	Implementation Cohort Cohort undergoing percutaneous nephrolithotomy (PCNL) with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Overall Study STARTED	20	10
Overall Study COMPLETED	14	6
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones

Baseline characteristics by cohort

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Previous nephrolithiasis requiring surgery	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year or until subject accrual is complete

Number of enrolled patients / patients approached

Outcome measures

Measure	Pre-Implementation Cohort n=20 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=10 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Protocol Feasibility	14 Participants	10 Participants

PRIMARY outcome

Timeframe: 30 days after procedure

Dropout of enrolled patients

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=10 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Adherence to the Protocol	14 Participants	6 Participants

PRIMARY outcome

Timeframe: Day of procedure to 30 days after procedure

Adverse events (AEs) while inpatient and following discharge

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Adverse Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 24 hours of discharge from hospital

Whether subject is discharged with prescription for opioids or not

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Opioid Free Discharge	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 24-48 hours

Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Postoperative Inpatient Opioid Utilization	4.0 morphine mEq / kg / day Interval 2.0 to 4.0	0 morphine mEq / kg / day Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At time of discharge, average of postoperative day 1

Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Discharge Opioid Prescriptions	30.0 morphine mEq / kg / day Interval 20.0 to 30.0	0 morphine mEq / kg / day Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At time of discharge, average of postoperative day 1

Nonopioid medications given for pain

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24-48 hours

Length of inpatient stay (hours)

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Length of Stay (Hours)	1 day(s) Interval 1.0 to 1.0	1 day(s) Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: 30 days

Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Clinic Calls	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Refill Requests	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR

Outcome measures

Measure	Pre-Implementation Cohort n=14 Participants Cohort undergoing PCNL prior to implementation of the novel nonopioid pathway	Implementation Cohort n=6 Participants Cohort undergoing PCNL with implementation of the novel nonopioid pathway Novel Nonopioid Pathway: The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Emergency Department Visits	2 Participants	0 Participants

Adverse Events

Pre-Implementation Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Implementation Cohort

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

David Sobel, MD

Maine Medical Center

Phone: 207-773-1728

Email: david.sobel@mainehealth.org

Results disclosure agreements

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