Trial Outcomes & Findings for Steroids in Occipital Nerve Block for Treatment of Headache (NCT NCT05732532)
NCT ID: NCT05732532
Last Updated: 2026-06-24
Results Overview
The change in the number of self-reported days subjects experienced headaches from baseline to 1 week.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
Baseline; 1 week
Results posted on
2026-06-24
Participant Flow
Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, or data anlaysis.
Participant milestones
| Measure |
Anesthetic Without Steroid Group
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
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|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
58
|
60
|
|
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 |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
48.5 years
STANDARD_DEVIATION 13.9 • n=58 Participants
|
44.6 years
STANDARD_DEVIATION 13.0 • n=60 Participants
|
46.5 years
STANDARD_DEVIATION 13.5 • n=118 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=58 Participants
|
56 Participants
n=60 Participants
|
107 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=58 Participants
|
4 Participants
n=60 Participants
|
11 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
|
58 participants
n=58 Participants
|
60 participants
n=60 Participants
|
118 participants
n=118 Participants
|
PRIMARY outcome
Timeframe: Baseline; 1 weekThe change in the number of self-reported days subjects experienced headaches from baseline to 1 week.
Outcome measures
| Measure |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
Change in Headache Days 1 Week Following Treatment
|
-1.8 days
Standard Deviation 2.2
|
-1.9 days
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline; 2 weeksThe change in the number of self-reported days subjects experienced headaches from baseline to 2 weeks
Outcome measures
| Measure |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
Change in Headache Days 2 Weeks Following Treatment
|
-2.3 days
Standard Deviation 2.2
|
-2.3 days
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Baseline; 4 weeksThe change in the number of self-reported days subjects experienced headaches from baseline to 4 weeks.
Outcome measures
| Measure |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
Change in Headache Days 4 Weeks Following Treatment
|
-2.5 days
Standard Deviation 2.1
|
-2.5 days
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline,1 week, 2 weeks, 4 weeksThe change in the self-reported average severity of subjects' headaches using a scale of 0-10, with 0=no pain and 10=worst pain possible following treatment with higher scores indicating worse pain.
Outcome measures
| Measure |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
Change in Headache Severity
Baseline to 1 Week
|
-2.4 score on a scale
Standard Deviation 2.4
|
-2.4 score on a scale
Standard Deviation 2.3
|
|
Change in Headache Severity
Baseline to 2 Weeks
|
-2.1 score on a scale
Standard Deviation 2.4
|
-2.3 score on a scale
Standard Deviation 2.2
|
|
Change in Headache Severity
Baseline to 4 Weeks
|
-1.7 score on a scale
Standard Deviation 2.6
|
-2.0 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 4 weeksThe change in the number of self-reported days subjects reported headaches as being moderate or severe following treatment
Outcome measures
| Measure |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
Change in Moderate or Severe Headache Days
Baseline to 4 Weeks
|
-2.4 days
Standard Deviation 2.5
|
-2.3 days
Standard Deviation 2.5
|
|
Change in Moderate or Severe Headache Days
Baseline to 1 Week
|
-2.1 days
Standard Deviation 2.6
|
-2.4 days
Standard Deviation 2.5
|
|
Change in Moderate or Severe Headache Days
Baseline to 2 Weeks
|
-2.7 days
Standard Deviation 2.4
|
-2.7 days
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 4 weeksThe change in the number of self-reported days subjects had to take acute pain medication for their headaches following treatment
Outcome measures
| Measure |
Anesthetic Without Steroid Group
n=58 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 Participants
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
Change in Acute Medication Use
Baseline to 1 Week
|
-2.1 days
Standard Deviation 2.8
|
-2.2 days
Standard Deviation 2.5
|
|
Change in Acute Medication Use
Baseline to 2 Weeks
|
-2.3 days
Standard Deviation 2.4
|
-2.3 days
Standard Deviation 2.4
|
|
Change in Acute Medication Use
Baseline to 4 Weeks
|
-2.0 days
Standard Deviation 2.5
|
-1.9 days
Standard Deviation 2.2
|
Adverse Events
Anesthetic Without Steroid Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Anesthetic With Dexamethasone Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Anesthetic Without Steroid Group
n=58 participants at risk
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and normal saline.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Normal saline: 0.5 mL of normal saline 0.9% injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
Anesthetic With Dexamethasone Group
n=60 participants at risk
Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care received standard of care medication, including lidocaine and bupivacaine and dexamethasone.
Bupivacaine: 2 mL of bupivacaine 0.5% (5 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Lidocaine: 0.5 mL of lidocaine 1% (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Dexamethasone: 0.5 mL of dexamethasone (10 mg/mL) injected at the origin of each bilateral greater and lesser occipital nerves
Greater/lesser occipital nerve blocks: Subjects received a total of 12 mL injectate divided equally between the 4 injection sites of the bilateral greater and lesser occipital nerves using the landmark-based technique.
|
|---|---|---|
|
General disorders
Tenderness/Neck Soreness at Injection Site
|
5.2%
3/58 • Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
|
8.3%
5/60 • Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
|
|
General disorders
Face Numbness
|
0.00%
0/58 • Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
|
1.7%
1/60 • Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
|
|
General disorders
Throat Numbness
|
1.7%
1/58 • Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
|
0.00%
0/60 • Adverse events were collected from the time of informed consent through study completion, approximately 1 month.
Adverse events were collected through examination immediately after treatment was administrated and specific questioning of the subjects at each follow up visit. Two participants randomization information was lost and therefore could not be included in the participant flow, demographics, adverse events or data analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place