Trial Outcomes & Findings for STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial (NCT NCT04491617)
NCT ID: NCT04491617
Last Updated: 2025-01-24
Results Overview
The proportion of patients satisfied with postoperative pain control will be reported. Patient satisfaction with pain control was assessed with a 5-point Likert scale at the postoperative visit ("Overall, how satisfied were you with your postoperative pain medication?" \[ranked 1- Very Dissatisfied to 5- Very Satisfied\] and those who ranked their satisfaction level as a 4 or 5 were considered satisfied.
COMPLETED
NA
129 participants
6-weeks
2025-01-24
Participant Flow
Participant milestones
| Measure |
Standard Opioid Protocol (Control)
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
|
Restrictive Opioid Protocol (Intervention)
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
65
|
|
Overall Study
COMPLETED
|
64
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial
Baseline characteristics by cohort
| Measure |
Standard Opioid Protocol (Control)
n=64 Participants
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
|
Restrictive Opioid Protocol (Intervention)
n=63 Participants
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
|
Total
n=127 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
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Continuous
|
56.7 years
n=5 Participants
|
55.9 years
n=7 Participants
|
56.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
122 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
63 participants
n=7 Participants
|
127 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-weeksThe proportion of patients satisfied with postoperative pain control will be reported. Patient satisfaction with pain control was assessed with a 5-point Likert scale at the postoperative visit ("Overall, how satisfied were you with your postoperative pain medication?" \[ranked 1- Very Dissatisfied to 5- Very Satisfied\] and those who ranked their satisfaction level as a 4 or 5 were considered satisfied.
Outcome measures
| Measure |
Standard Opioid Protocol (Control)
n=64 Participants
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
|
Restrictive Opioid Protocol (Intervention)
n=63 Participants
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
|
|---|---|---|
|
Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit
|
59 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: 1-weekPatients will be asked to report their pain level for the first 7 days postoperatively. Pain levels will be assessed using questions 1, 2 and 4 from the Modified Surgical Pain Scales (SPS), which measures pain at rest, during normal activities and quantifies unpleasantness of worst pain using an 11-point numeric rating score, with 0 representing 'No pain sensation' and 10 representing 'Most intense pain imaginable'. Higher scores indicate a greater amount of pain. REDCap or paper surveys will be used.
Outcome measures
| Measure |
Standard Opioid Protocol (Control)
n=64 Participants
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
|
Restrictive Opioid Protocol (Intervention)
n=65 Participants
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
|
|---|---|---|
|
Pain Level Scores During First Postoperative Week
Day 5
|
3 score on a scale
Interval 2.0 to 6.0
|
3 score on a scale
Interval 2.0 to 6.0
|
|
Pain Level Scores During First Postoperative Week
Day 6
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Pain Level Scores During First Postoperative Week
Day 7
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Pain Level Scores During First Postoperative Week
Day 1
|
7 score on a scale
Interval 4.0 to 8.0
|
6 score on a scale
Interval 3.0 to 8.0
|
|
Pain Level Scores During First Postoperative Week
Day 2
|
6 score on a scale
Interval 3.0 to 8.0
|
5 score on a scale
Interval 3.0 to 8.0
|
|
Pain Level Scores During First Postoperative Week
Day 3
|
5 score on a scale
Interval 3.0 to 7.0
|
4 score on a scale
Interval 2.0 to 7.0
|
|
Pain Level Scores During First Postoperative Week
Day 4
|
4 score on a scale
Interval 2.0 to 6.0
|
4 score on a scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 1-weekParticipants will be asked to log opioid and non-opioid medication in number of tablets used during the first postoperative week with either REDCap or paper surveys. The opioid usage by study arm was reported in mean morphine equivalents (MMEs).
Outcome measures
| Measure |
Standard Opioid Protocol (Control)
n=64 Participants
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
|
Restrictive Opioid Protocol (Intervention)
n=65 Participants
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
|
|---|---|---|
|
Opioid Usage in the First Postoperative Week
|
0 MMEs
Interval 0.0 to 15.0
|
0 MMEs
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 6-weeksInvestigators will track the number of participants who requested a new opioid prescription or opioid refill during the 6 week postoperative period.
Outcome measures
| Measure |
Standard Opioid Protocol (Control)
n=64 Participants
Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
Standard opioid prescribing: Patients are routinely prescribed opioid medications in addition to non-opioids.
|
Restrictive Opioid Protocol (Intervention)
n=30 Participants
Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
Restrictive opioid prescribing: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
|
|---|---|---|
|
Number of Participants Who Requested a New Opioid Prescription or Opioid Refill
|
6 Participants
|
2 Participants
|
Adverse Events
Standard Opioid Protocol (Control)
Restrictive Opioid Protocol (Intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place