Trial Outcomes & Findings for Effect of Epinephrine on Post-polypectomy Pain (NCT NCT04065451)
NCT ID: NCT04065451
Last Updated: 2022-09-30
Results Overview
Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain
COMPLETED
PHASE4
22 participants
30 minutes after the procedure
2022-09-30
Participant Flow
Twenty-two patients consented to participate in the trial, but two patients were not randomized to either of the study arms. One patient did not have a polyp to remove (referred polyp was a lipoma). The other patient had poor bowel preparation, and the procedure was aborted.
Participant milestones
| Measure |
Epinephrine
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Epinephrine on Post-polypectomy Pain
Baseline characteristics by cohort
| Measure |
Epinephrine
n=11 Other Units (Polyps)
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 Other Units (Polyps)
Submucosal injection fluid without epinephrine
|
Total
n=21 Other Units (Polyps)
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Polyp Size
|
46.7 millimeters
STANDARD_DEVIATION 28.3 • n=5 Participants
|
40.4 millimeters
STANDARD_DEVIATION 16.1 • n=7 Participants
|
43.7 millimeters
STANDARD_DEVIATION 23.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after the procedurePain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain
Outcome measures
| Measure |
Epinephrine
n=10 Participants
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 Participants
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Immediate Post-polypectomy Pain
|
46.5 units on a scale
Standard Deviation 32.4
|
13.6 units on a scale
Standard Deviation 25.9
|
PRIMARY outcome
Timeframe: 1 hour after procedurePain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain
Outcome measures
| Measure |
Epinephrine
n=10 Participants
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 Participants
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Immediate Post Polypectomy Pain (1hour)
|
44 Units on a Scale
Standard Deviation 27.7
|
12.9 Units on a Scale
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, an average of 47.3 minutesPopulation: One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.
Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
Outcome measures
| Measure |
Epinephrine
n=11 Polyps
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 Polyps
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
en Bloc Resection
En bloc removal
|
0 Polyps
|
0 Polyps
|
|
en Bloc Resection
Piecemeal removal
|
11 Polyps
|
10 Polyps
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, an average of 47.3 minutesPopulation: Only lesions removed by EMR with electrocautery (heat) are included.
size of the polyp in mm divided by the number of pieces the polyps is removed in
Outcome measures
| Measure |
Epinephrine
n=7 Polyps
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=9 Polyps
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Sydney Resection Quotient
|
5 Ratio
Interval 4.1 to 6.3
|
4.2 Ratio
Interval 3.1 to 5.6
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, an average of 47.3 minutesPopulation: One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.
Endoscopist impression of lift provided by the submucosal injection: excellent/adequate or insufficient. Excellent is the best rating and insufficient is the worst rating on this scale.
Outcome measures
| Measure |
Epinephrine
n=11 Polyps
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 Polyps
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Quality of the Mound
Excellent/adequate
|
9 Polyps
|
8 Polyps
|
|
Quality of the Mound
insufficient
|
0 Polyps
|
2 Polyps
|
|
Quality of the Mound
Unknown
|
2 Polyps
|
0 Polyps
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, an average of 47.3 minutesPopulation: One patient in the epinephrine group had two eligible polyps for the study so there ended up being 11 polyps in the epinephrine arm.
Number of polyps with intraprocedural bleeding during removal
Outcome measures
| Measure |
Epinephrine
n=11 Polyps
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 Polyps
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Frequency of Immediate Bleeding
Bleeding
|
2 Polyps
|
4 Polyps
|
|
Frequency of Immediate Bleeding
No bleeding
|
9 Polyps
|
6 Polyps
|
Adverse Events
Epinephrine
No Epinephrine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epinephrine
n=10 participants at risk
Epinephrine in the submucosal injection fluid (1:200,000)
Epinephrine: Epinephrine in the submucosal injection fluid
|
No Epinephrine
n=10 participants at risk
Submucosal injection fluid without epinephrine
|
|---|---|---|
|
Injury, poisoning and procedural complications
delayed bleeding
|
0.00%
0/10 • 30 days
Patients were assessed for adverse events that occurred within 30 days after the procedure
|
10.0%
1/10 • Number of events 1 • 30 days
Patients were assessed for adverse events that occurred within 30 days after the procedure
|
|
Injury, poisoning and procedural complications
abdominal pain
|
10.0%
1/10 • Number of events 1 • 30 days
Patients were assessed for adverse events that occurred within 30 days after the procedure
|
0.00%
0/10 • 30 days
Patients were assessed for adverse events that occurred within 30 days after the procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place