Trial Outcomes & Findings for Stellate Ganglion Block for COVID-induced Parosmia (NCT NCT06253806)
NCT ID: NCT06253806
Last Updated: 2025-11-10
Results Overview
The primary outcome of the study is to determine the efficacy of a stellate ganglion block (SGB) in improving parosmia-related quality of life compared to a saline injection placebo. The instrument contains 28 total items with each scored on a 5-point Likert scale from 0 (no difficulty) to 4 (complete difficulty or very frequent bother). Higher total scores indicate a greater degree of dysfunction and limitation. The minimal clinically important difference (MCID) for DisODOR being 15 points.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
1-mo outcome and 3-mo outcome
Results posted on
2025-11-10
Participant Flow
48 participants were enrolled and randomized, with 32 receiving SGB and 16 receiving placebo.
Participant milestones
| Measure |
Experimental: Stellate Ganglion Block
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
16
|
|
Overall Study
1-mo Outcome
|
31
|
16
|
|
Overall Study
3-mo Outcome
|
30
|
16
|
|
Overall Study
COMPLETED
|
30
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stellate Ganglion Block for COVID-induced Parosmia
Baseline characteristics by cohort
| Measure |
Stellate Ganglion Block
n=32 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the ne
|
Placebo Sham Injections
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
55 years
n=20 Participants
|
46 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
13 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
15 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
31 Participants
n=5 Participants
|
14 Participants
n=20 Participants
|
45 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
16 participants
n=20 Participants
|
48 participants
n=40 Participants
|
|
The Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR)
|
63 scores ranging 0-116
n=5 Participants
|
66 scores ranging 0-116
n=20 Participants
|
66 scores ranging 0-116
n=40 Participants
|
|
The Clinical Global Impression - Severity Scale (CGI-S) smell loss
No loss
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
The Clinical Global Impression - Severity Scale (CGI-S) smell loss
Very mild to mild loss
|
6 Participants
n=5 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
The Clinical Global Impression - Severity Scale (CGI-S) smell loss
Moderate to severe loss
|
25 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
The Clinical Global Impression - Severity Scale (CGI-S) smell distortion
No distortion
|
3 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
The Clinical Global Impression - Severity Scale (CGI-S) smell distortion
very mild to mild distortion
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
The Clinical Global Impression - Severity Scale (CGI-S) smell distortion
Moderate to severe distortion
|
28 Participants
n=5 Participants
|
13 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
|
The Olfaction Catastrophizing Scale
|
35 scores on a scale 0-52
n=5 Participants
|
34 scores on a scale 0-52
n=20 Participants
|
34 scores on a scale 0-52
n=40 Participants
|
|
HADS anxiety score
|
7 scores ranging 0-21
n=5 Participants
|
9 scores ranging 0-21
n=20 Participants
|
8 scores ranging 0-21
n=40 Participants
|
|
HADS depression total score
|
7 scores ranging 0-21
n=5 Participants
|
6 scores ranging 0-21
n=20 Participants
|
7 scores ranging 0-21
n=40 Participants
|
|
The University of Pennsylvania Smell Identification Test (UPSIT)
|
24 scores ranging 0-40
n=5 Participants
|
25 scores ranging 0-40
n=20 Participants
|
25 scores ranging 0-40
n=40 Participants
|
|
Expectations (How confident are you that this treatment will improve your smell loss
Not at all
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Expectations (How confident are you that this treatment will improve your smell loss
Slightly confident
|
9 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Expectations (How confident are you that this treatment will improve your smell loss
Somewhat confident
|
12 Participants
n=5 Participants
|
9 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Expectations (How confident are you that this treatment will improve your smell loss
Very confident
|
7 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Expectations (How confident are you that this treatment will improve your smell loss
Extremely confident
|
4 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Blind assessment
Active medication
|
18 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Blind assessment
Placebo
|
14 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 1-mo outcome and 3-mo outcomePopulation: 1-mo outcome SGB(n=31) patient were analyzed 3-mo outcome SGB (n=30) patients were analyzed. One patient was excluded from the analysis
The primary outcome of the study is to determine the efficacy of a stellate ganglion block (SGB) in improving parosmia-related quality of life compared to a saline injection placebo. The instrument contains 28 total items with each scored on a 5-point Likert scale from 0 (no difficulty) to 4 (complete difficulty or very frequent bother). Higher total scores indicate a greater degree of dysfunction and limitation. The minimal clinically important difference (MCID) for DisODOR being 15 points.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Parosmia Olfactory Dysfunction Outcomes Rating
1-mo
|
9 score on a scale 0-112
Interval -19.0 to 54.0
|
9 score on a scale 0-112
Interval -13.0 to 82.0
|
|
Parosmia Olfactory Dysfunction Outcomes Rating
3-mo
|
14 score on a scale 0-112
Interval -21.0 to 59.0
|
11 score on a scale 0-112
Interval -16.0 to 60.0
|
SECONDARY outcome
Timeframe: 1-mo and 3-moPopulation: Forty-seven participants (98%) completed 1-month surveys, and 46 participants (96%) completed 3-month surveys.
The Clinical Global Impression - Improvement Scale (CGI-I) for smell loss (parosmia) is used to measure the overall response to treatment by assessing changes in the clinical condition compared to before the stellate ganglion block. It uses a 7-point Likert scale with the following response options: (1) Much better now than before, (2) Moderately better now than before, (3) Slightly better now than before, (4) About the same, (5) Slightly worse now than before, (6) Moderately worse now than before, and (7) Much worse now than before. Participants who report "slightly better now than before" or greater improvement are classified as responders.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss
1-mo · slightly to much better
|
8 Participants
|
4 Participants
|
|
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss
1-mo · about the same
|
22 Participants
|
11 Participants
|
|
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss
1-mo · slightly to much worse
|
1 Participants
|
1 Participants
|
|
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss
3-mo · slightly to much better
|
13 Participants
|
6 Participants
|
|
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss
3-mo · about the same
|
13 Participants
|
10 Participants
|
|
Clinical Global Impression - Severity Scale (CGI-S) Smell Loss
3-mo · slightly to much worse
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month, 3 monthsPopulation: Forty-seven participants (98%) completed 1-month surveys, and 46 participants (96%) completed 3-month surveys.
At each follow-up visit, participants are asked to rank their overall improvement in each of the 11 symptoms compared to their symptoms prior to their first SGB. The improvement options are based on the CGI-I 7-point Likert scale. Total scores range from 0-77, with higher scores being worse and lower scores being better.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Long-COVID Questionnaire
3-mo
|
44 score on a scale 0-77
Interval 16.0 to 74.0
|
44 score on a scale 0-77
Interval 11.0 to 53.0
|
|
Long-COVID Questionnaire
1-mo
|
44 score on a scale 0-77
Interval 21.0 to 68.0
|
45 score on a scale 0-77
Interval 11.0 to 69.0
|
SECONDARY outcome
Timeframe: 1 month, 3 monthsPopulation: Forty-seven participants (98%) completed 1-month surveys, and 46 participants (96%) completed 3-month surveys
Participants will be asked to complete the OCS, which measures the negative mental response to smell dysfunction loss. Multiple thoughts/feelings will be assessed on a 5-point Likert scale with a maximum score of 52. Participants will complete the OCS at each study visit to assess the degree of olfactory-related catastrophizing over time.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Olfaction Catastrophizing Scale (OCS)
1-mo
|
8 units on a scale
Interval -6.0 to 32.0
|
6 units on a scale
Interval -5.0 to 38.0
|
|
Olfaction Catastrophizing Scale (OCS)
3-mo
|
7 units on a scale
Interval -13.0 to 31.0
|
5 units on a scale
Interval -8.0 to 33.0
|
SECONDARY outcome
Timeframe: 1 month, 3 monthsPopulation: Forty-seven participants (98%) completed 1-month surveys, and 46 participants (96%) completed 3-month surveys
Participants will be asked to complete the HADS, which screens for both anxiety and depression in the general population. It consists of 7 questions for anxiety and 7 questions for depression each ranked on a 4-point Likert Scale. A score of 0-7 is considered normal, 8-10 is borderline abnormal anxiety or depression, and a score of 11-21 corresponds with screening positive for anxiety or depression.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
1-mo HADS anxiety
|
1 units on a scale
Interval -6.0 to 10.0
|
1 units on a scale
Interval -5.0 to 10.0
|
|
Hospital Anxiety and Depression Scale (HADS)
3-mo HADS anxiety
|
1 units on a scale
Interval -8.0 to 18.0
|
1 units on a scale
Interval -8.0 to 8.0
|
|
Hospital Anxiety and Depression Scale (HADS)
1-mo HADS depression
|
1 units on a scale
Interval -7.0 to 10.0
|
1 units on a scale
Interval -4.0 to 8.0
|
|
Hospital Anxiety and Depression Scale (HADS)
3-mo HADS depression
|
8 units on a scale
Interval -6.0 to 32.0
|
3 units on a scale
Interval -7.0 to 7.0
|
SECONDARY outcome
Timeframe: 1 mo, 3-moPopulation: Forty-seven participants (98%) completed 1-month surveys, and 46 participants (96%) completed 3-month surveys
Participants will be asked at 1 month "Overall, how satisfied were you with the stellate ganglion block treatment for your parosmia?" with possible answer choices: 1) Completely dissatisfied, 2) Mostly dissatisfied, 3) Somewhat dissatisfied, 4) Neither satisfied or dissatisfied, 5) Somewhat satisfied, 6) Mostly satisfied, 7) Completely satisfied.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Patient Satisfaction With Treatment
1-mo · Somewhat to completely satisfied
|
8 Participants
|
5 Participants
|
|
Patient Satisfaction With Treatment
1-mo · Neither satisfied or dissatisfied
|
10 Participants
|
4 Participants
|
|
Patient Satisfaction With Treatment
1-mo · Somewhat to completely dissatisfied
|
13 Participants
|
7 Participants
|
|
Patient Satisfaction With Treatment
3-mo · Somewhat to completely satisfied
|
11 Participants
|
5 Participants
|
|
Patient Satisfaction With Treatment
3-mo · Neither satisfied or dissatisfied
|
1 Participants
|
5 Participants
|
|
Patient Satisfaction With Treatment
3-mo · Somewhat to completely dissatisfied
|
18 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: during first visitPopulation: Forty-seven participants (98%) completed 1-month surveys, and 46 participants (96%) completed 3-month surveys.
Immediately after the injection, participants will be asked "Which intervention do you think you received?" with answer choices of 1) Mepivacaine (active medication) or 2) Saline (placebo). It is performed immediately after the initial injection during the first visit, just prior to discharge.
Outcome measures
| Measure |
Experimental: Stellate Ganglion Block
n=31 Participants
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 Participants
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
Assessment of the Blind
1-mo blind assessment
|
18 Participants
|
14 Participants
|
|
Assessment of the Blind
3-mo blind assessment
|
12 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 1 month, 3 monthsAny potential adverse events of the stellate ganglion block will be collected from participants.
Outcome measures
Outcome data not reported
Adverse Events
Experimental: Stellate Ganglion Block
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo: Sham Injection
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Stellate Ganglion Block
n=31 participants at risk
The ultrasound guided stellate ganglion blocks will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these blocks. Laterality of the stellate ganglion blocks will be randomized between the left and right sides of the neck.
Stellate Ganglion Block: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 1% mepivacaine will be injected near the stellate ganglion.
|
Placebo: Sham Injection
n=16 participants at risk
The ultrasound guided placebo sham injections will be performed at the initial visit by a board-certified anesthesiologist and pain management specialist with extensive experience performing these injections. Laterality of the placebo sham injections will be randomized between the left and right sides of the neck.
Placebo Sham Injection: The stellate ganglion will be identified using ultrasound guidance, and after negative aspiration, 6-8 mL of 0.9% saline will be injected near the stellate ganglion.
|
|---|---|---|
|
General disorders
transient voice hoarseness
|
29.0%
9/31 • Number of events 9 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
|
0.00%
0/16 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
|
|
General disorders
nasal congestion
|
19.4%
6/31 • Number of events 6 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
|
0.00%
0/16 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
|
|
General disorders
headache or migraine
|
16.1%
5/31 • Number of events 5 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
|
6.2%
1/16 • Number of events 1 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
|
|
General disorders
lightheadedness or dizziness
|
16.1%
5/31 • Number of events 5 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
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6.2%
1/16 • Number of events 1 • Adverse events will be recorded from the time of dose administration (the stellate ganglion block or placebo injection) through the post-dose period and up to the final follow-up visit at approximately 3 months after the injection. The study team will monitor and document all adverse events throughout this entire timeframe.
All AEs will be documented and assessed for their relatedness to the study medication. The study team will monitor AEs continuously, and once aware of an AE, it will be reported according to institutional guidelines. Serious Adverse Events (SAEs) or Unexpected Adverse Events will be investigated by the study monitoring board and reported to Washington University HRPO following required reporting procedures.
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Additional Information
Nyssa Farrell, MD
Washington University, Department of Otolaryngology - Head and Neck Surgery
Phone: 314-273-2490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place