Trial Outcomes & Findings for Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery (NCT NCT03757715)
NCT ID: NCT03757715
Last Updated: 2022-08-31
Results Overview
Self-report of pain score on a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable"
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
10 days
Results posted on
2022-08-31
Participant Flow
No patients were excluded prior to assignment.
Participant milestones
| Measure |
Treatment Group
20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
Bupivacaine: 20 mL of 1.3% bupivacaine
Dexamethasone: 2 mg dexamethasone
|
Control Group
No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
25
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Treatment Group
20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
Bupivacaine: 20 mL of 1.3% bupivacaine
Dexamethasone: 2 mg dexamethasone
|
Control Group
No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
Baseline characteristics by cohort
| Measure |
Treatment Group
n=16 Participants
20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
Bupivacaine: 20 mL of 1.3% bupivacaine
Dexamethasone: 2 mg dexamethasone
|
Control Group
n=15 Participants
No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.69 years
STANDARD_DEVIATION 17.79 • n=5 Participants
|
36.73 years
STANDARD_DEVIATION 13.10 • n=7 Participants
|
42.90 years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 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
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Body Mass Index
|
31.19 kg/m^2
STANDARD_DEVIATION 7.66 • n=5 Participants
|
31.71 kg/m^2
STANDARD_DEVIATION 11.10 • n=7 Participants
|
31.44 kg/m^2
STANDARD_DEVIATION 9.32 • n=5 Participants
|
|
Diabetes
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diabetes
No
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Anxiety/Depression
No
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Anxiety/Depression
Yes
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Migraine
No
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Migraine
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Obstructive Sleep Apnea
No
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Obstructive Sleep Apnea
Yes
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Both groups were analyzed on the average number of pain pills taken during the post-operative time and average pain scores per day postoperatively
Self-report of pain score on a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable"
Outcome measures
| Measure |
Treatment Group
n=16 Participants
20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
Bupivacaine: 20 mL of 1.3% bupivacaine
Dexamethasone: 2 mg dexamethasone
|
Control Group
n=15 Participants
No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
|
|---|---|---|
|
Participant Pain Control
POD 0
|
4.5 units on a scale
Standard Deviation 2.83
|
5.87 units on a scale
Standard Deviation 2.85
|
|
Participant Pain Control
POD1
|
4.63 units on a scale
Standard Deviation 1.86
|
5.00 units on a scale
Standard Deviation 1.96
|
|
Participant Pain Control
POD 2
|
4.06 units on a scale
Standard Deviation 1.84
|
4.13 units on a scale
Standard Deviation 1.89
|
|
Participant Pain Control
POD 3
|
4.13 units on a scale
Standard Deviation 1.46
|
3.20 units on a scale
Standard Deviation 2.01
|
|
Participant Pain Control
POD 4
|
3.38 units on a scale
Standard Deviation 1.93
|
2.67 units on a scale
Standard Deviation 2.02
|
|
Participant Pain Control
POD 5
|
3.00 units on a scale
Standard Deviation 2.42
|
2.33 units on a scale
Standard Deviation 1.76
|
|
Participant Pain Control
POD 6
|
3.00 units on a scale
Standard Deviation 2.58
|
2.2 units on a scale
Standard Deviation 1.7
|
|
Participant Pain Control
POD 7
|
2.56 units on a scale
Standard Deviation 2.45
|
2.13 units on a scale
Standard Deviation 1.6
|
|
Participant Pain Control
POD 8
|
2.13 units on a scale
Standard Deviation 2.45
|
1.67 units on a scale
Standard Deviation 1.76
|
|
Participant Pain Control
POD 9
|
2.19 units on a scale
Standard Deviation 2.34
|
1.73 units on a scale
Standard Deviation 2.22
|
|
Participant Pain Control
POD 10
|
2.13 units on a scale
Standard Deviation 2.50
|
1.27 units on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: 10 daysAmount of opioid medication used, based on pill count
Outcome measures
| Measure |
Treatment Group
n=16 Participants
20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
Bupivacaine: 20 mL of 1.3% bupivacaine
Dexamethasone: 2 mg dexamethasone
|
Control Group
n=15 Participants
No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
|
|---|---|---|
|
Opioid Medication Use
POD 10
|
0.31 pills consumed
Standard Deviation 0.60
|
0.27 pills consumed
Standard Deviation 0.80
|
|
Opioid Medication Use
POD 0
|
1.38 pills consumed
Standard Deviation 1.03
|
1.07 pills consumed
Standard Deviation 1.22
|
|
Opioid Medication Use
POD 1
|
2.31 pills consumed
Standard Deviation 1.40
|
1.87 pills consumed
Standard Deviation 1.92
|
|
Opioid Medication Use
POD 2
|
1.69 pills consumed
Standard Deviation 1.66
|
1.40 pills consumed
Standard Deviation 1.81
|
|
Opioid Medication Use
POD 3
|
1.63 pills consumed
Standard Deviation 1.45
|
1.07 pills consumed
Standard Deviation 1.39
|
|
Opioid Medication Use
POD 4
|
0.97 pills consumed
Standard Deviation 1.49
|
1.00 pills consumed
Standard Deviation 1.36
|
|
Opioid Medication Use
POD 5
|
0.594 pills consumed
Standard Deviation 1.11
|
0.567 pills consumed
Standard Deviation 1.23
|
|
Opioid Medication Use
POD 6
|
0.50 pills consumed
Standard Deviation 1.09
|
0.30 pills consumed
Standard Deviation 0.79
|
|
Opioid Medication Use
POD 7
|
0.38 pills consumed
Standard Deviation 0.885
|
0.27 pills consumed
Standard Deviation 0.799
|
|
Opioid Medication Use
POD 8
|
0.25 pills consumed
Standard Deviation 0.577
|
0.20 pills consumed
Standard Deviation 0.775
|
|
Opioid Medication Use
POD 9
|
0.31 pills consumed
Standard Deviation 0.60
|
0.27 pills consumed
Standard Deviation 1.03
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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