Trial Outcomes & Findings for Perioperative Pregabalin in Ureteroscopy (NCT NCT04122196)
NCT ID: NCT04122196
Last Updated: 2025-11-12
Results Overview
This was a visual analogue scale of pain as described in Ahles et al 1984. The patients were given a paper with a 10cm horizontal line on it. On the left was marked "No pain" and on the right "Worst pain imaginable". The patients were then asked to mark a vertical line along the 10cm line that indicated where their pain was. The score is the number of centimeters from the left. 0 is minimum (best). 10 maximum (worst).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
118 participants
Primary outcome timeframe
1 hour after arrival to post anesthesia care unit
Results posted on
2025-11-12
Participant Flow
Participant milestones
| Measure |
Pregabalin 300mg
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
59
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=59 Participants
|
57 years
n=59 Participants
|
49 years
n=118 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=59 Participants
|
31 Participants
n=59 Participants
|
67 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=59 Participants
|
28 Participants
n=59 Participants
|
51 Participants
n=118 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
59 participants
n=59 Participants
|
59 participants
n=59 Participants
|
118 participants
n=118 Participants
|
|
Total oral morphine equivalents in 30 days prior
|
8 mg
n=59 Participants
|
0 mg
n=59 Participants
|
4 mg
n=118 Participants
|
|
Preoperative alpha blocker
|
27 Participants
n=59 Participants
|
28 Participants
n=59 Participants
|
55 Participants
n=118 Participants
|
|
First ureteroscopy
|
48 Participants
n=59 Participants
|
46 Participants
n=59 Participants
|
94 Participants
n=118 Participants
|
|
Prestented
|
23 Participants
n=59 Participants
|
15 Participants
n=59 Participants
|
38 Participants
n=118 Participants
|
|
Preoperative Watson Clock Test Score
|
2 units on a scale
n=59 Participants
|
2 units on a scale
n=59 Participants
|
2 units on a scale
n=118 Participants
|
|
Preoperative visual analogue scale of pain
|
0.6 units on a scale
n=59 Participants
|
0.5 units on a scale
n=59 Participants
|
0.6 units on a scale
n=118 Participants
|
|
Stone location
Renal
|
18 Participants
n=59 Participants
|
13 Participants
n=59 Participants
|
31 Participants
n=118 Participants
|
|
Stone location
Ureteral
|
38 Participants
n=59 Participants
|
39 Participants
n=59 Participants
|
77 Participants
n=118 Participants
|
|
Stone location
None
|
3 Participants
n=59 Participants
|
7 Participants
n=59 Participants
|
10 Participants
n=118 Participants
|
|
Laterality
Bilateral
|
5 Participants
n=59 Participants • Information not available for one participant
|
6 Participants
n=58 Participants • Information not available for one participant
|
11 Participants
n=117 Participants • Information not available for one participant
|
|
Laterality
Left
|
32 Participants
n=59 Participants • Information not available for one participant
|
30 Participants
n=58 Participants • Information not available for one participant
|
62 Participants
n=117 Participants • Information not available for one participant
|
|
Laterality
Right
|
22 Participants
n=59 Participants • Information not available for one participant
|
22 Participants
n=58 Participants • Information not available for one participant
|
44 Participants
n=117 Participants • Information not available for one participant
|
|
Stented at ureteroscopy
|
45 Participants
n=59 Participants
|
48 Participants
n=59 Participants
|
93 Participants
n=118 Participants
|
|
Sheath
|
35 Participants
n=59 Participants
|
31 Participants
n=59 Participants
|
66 Participants
n=118 Participants
|
|
Procedure length
|
37 minutes
n=59 Participants
|
38 minutes
n=59 Participants
|
38 minutes
n=118 Participants
|
|
In-facility belladonna-opium suppository
|
14 Participants
n=59 Participants
|
11 Participants
n=59 Participants
|
25 Participants
n=118 Participants
|
|
In-facility non-steroidal anti-inflammatory drug
|
35 Participants
n=59 Participants
|
35 Participants
n=59 Participants
|
70 Participants
n=118 Participants
|
PRIMARY outcome
Timeframe: 1 hour after arrival to post anesthesia care unitThis was a visual analogue scale of pain as described in Ahles et al 1984. The patients were given a paper with a 10cm horizontal line on it. On the left was marked "No pain" and on the right "Worst pain imaginable". The patients were then asked to mark a vertical line along the 10cm line that indicated where their pain was. The score is the number of centimeters from the left. 0 is minimum (best). 10 maximum (worst).
Outcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Visual Analog Scale of Pain Score
|
3.7 units on a scale
Interval 1.5 to 6.3
|
2.0 units on a scale
Interval 0.6 to 4.2
|
SECONDARY outcome
Timeframe: Within the first 30 days post-operationOutcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Oral Morphine Equivalents of Opioids Prescribed
|
60 mg
Interval 13.0 to 90.0
|
50 mg
Interval 0.0 to 60.0
|
SECONDARY outcome
Timeframe: Within the first 30 days post-operationOutcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Proportion of Patients With Narcotic Prescription
|
44 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Within the first 30 days post-operationUnplanned healthcare interactions include unplanned visits, emergency room visits, admissions to the hospital, and phone calls
Outcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Number of Unplanned Healthcare Interactions
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Within the first 30 days post-operationComposite of unplanned serious adverse events including intensive care unit stay and death
Outcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Number of Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 hour after arrival to post anesthesia care unitThis score is based on the scoring method described in Watson et al 1993. Higher scores demonstrate more errors. A clock is drawn. This is divided into quadrants. For errors in quadrants 1-3 (clock 12-8), a score of 1 is assigned. For errors in quadrant 4, a score of 4 is assigned. The scores are summed. Total scores range from 0 to 7 with 7 representing significant impairment (worst) and 0 representing no impairment (best).
Outcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Watson Clock Drawing Test Score
|
1.8 units on a scale
Standard Deviation 2.1
|
1.8 units on a scale
Standard Deviation 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of surgeryOutcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
In-facility Oral Morphine Equivalents
|
38 mg
Interval 30.0 to 63.0
|
35 mg
Interval 30.0 to 48.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: In post anesthesia care unit (usually approximately 1 hour post op)Outcome measures
| Measure |
Pregabalin 300mg
n=59 Participants
Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
Pregabalin 300mg: Patient will receive a compounded version of 300mg pregabalin PO approximately one hour before surgery.
|
Placebo
n=59 Participants
Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
Placebo oral tablet: Patient will receive a compounded version of inactive placebo PO approximately one hour before surgery.
|
|---|---|---|
|
Nausea/Vomiting in PACU
|
2 Participants
|
0 Participants
|
Adverse Events
Pregabalin 300mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place