Trial Outcomes & Findings for Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation (NCT NCT04814433)
NCT ID: NCT04814433
Last Updated: 2024-06-26
Results Overview
Measured by self-reported level of pain recorded in a daily pain diary made by the researchers from the day of the surgery until post-operative day 14. The levels of pain are scored in the following manner: 1-2 no pain, 3-4 mild pain, 5-6 moderate pain, 7-8 severe pain, 9-10 worst pain imaginable.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
Day 1 preoperative , Day 14 postoperative
Results posted on
2024-06-26
Participant Flow
Participant milestones
| Measure |
Topical Lidocaine and Bupivacaine Alone
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
|
Topical Lidocaine and Bupivacaine With Thrombin
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
|
Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
|
Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
9
|
11
|
|
Overall Study
COMPLETED
|
8
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
4
|
5
|
Reasons for withdrawal
| Measure |
Topical Lidocaine and Bupivacaine Alone
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
|
Topical Lidocaine and Bupivacaine With Thrombin
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
|
Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
|
Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
|
|---|---|---|---|---|
|
Overall Study
Survey not returned
|
4
|
8
|
4
|
5
|
Baseline Characteristics
Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Baseline characteristics by cohort
| Measure |
Topical Lidocaine and Bupivacaine Alone
n=8 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
|
Topical Lidocaine and Bupivacaine With Thrombin
n=6 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
|
Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid
n=5 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
|
Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid
n=6 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
57 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
61 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
53 years
STANDARD_DEVIATION 3.4 • n=4 Participants
|
56 years
STANDARD_DEVIATION 3.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 preoperative , Day 14 postoperativeMeasured by self-reported level of pain recorded in a daily pain diary made by the researchers from the day of the surgery until post-operative day 14. The levels of pain are scored in the following manner: 1-2 no pain, 3-4 mild pain, 5-6 moderate pain, 7-8 severe pain, 9-10 worst pain imaginable.
Outcome measures
| Measure |
Topical Lidocaine and Bupivacaine Alone
n=8 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
|
Topical Lidocaine and Bupivacaine With Thrombin
n=6 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
|
Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid
n=5 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
|
Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid
n=6 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
|
|---|---|---|---|---|
|
Change in Postoperative Pain Control
|
4.8 units on a scale
Interval 3.0 to 8.0
|
4.4 units on a scale
Interval 4.0 to 5.0
|
5.1 units on a scale
Interval 2.0 to 7.0
|
4.7 units on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: From Day 1 postoperative to Day 14 postoperativeMeasured by self-reported number of pain pills taken postoperatively until post-operative day 14.
Outcome measures
| Measure |
Topical Lidocaine and Bupivacaine Alone
n=8 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine
|
Topical Lidocaine and Bupivacaine With Thrombin
n=6 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin
|
Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid
n=5 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid
|
Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid
n=6 Participants
In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid
|
|---|---|---|---|---|
|
Amount of Opioid Pain Medication Required Postoperatively
|
5.5 Pills
Interval 1.0 to 9.0
|
5 Pills
Interval 2.0 to 8.0
|
5.7 Pills
Interval 1.0 to 10.0
|
6 Pills
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: From Day 1 postoperative until discharge from PACU (up to 1 day)Population: The outcome measure "total time in PACU" was not able to be assessed because there was no consistent measurement taken during the study by PACU nurses of this time period.
Outcome measures
Outcome data not reported
Adverse Events
Topical Lidocaine and Bupivacaine Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Lidocaine and Bupivacaine With Thrombin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid
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