Trial Outcomes & Findings for Greater Occipital Nerve Block With Bupivacaine for Acute Migraine (NCT NCT02665273)

NCT ID: NCT02665273

Last Updated: 2020-08-11

Results Overview

Pain assessed using a standard ordinal headache intensity scale, in which subjects describe their headache as "severe", "moderate", "mild", or "none". Those with headache level = none, experience freedom from headache.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 28 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2020-08-11

Participant Flow

Participant milestones

Measure	Greater Occipital Nerve Block Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Overall Study STARTED	13	15
Overall Study COMPLETED	13	15
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	Greater Occipital Nerve Block n=13 Participants Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham n=15 Participants Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally	Total n=28 Participants Total of all reporting groups
Age, Continuous	35 years STANDARD_DEVIATION 10 • n=13 Participants	40 years STANDARD_DEVIATION 12 • n=15 Participants	38 years STANDARD_DEVIATION 11 • n=28 Participants
Sex: Female, Male Female	12 Participants n=13 Participants	12 Participants n=15 Participants	24 Participants n=28 Participants
Sex: Female, Male Male	1 Participants n=13 Participants	3 Participants n=15 Participants	4 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	13 participants n=13 Participants	15 participants n=15 Participants	28 participants n=28 Participants
Duration of headache	96 hours n=13 Participants	48 hours n=15 Participants	72 hours n=28 Participants

PRIMARY outcome

Timeframe: 30 minutes

Pain assessed using a standard ordinal headache intensity scale, in which subjects describe their headache as "severe", "moderate", "mild", or "none". Those with headache level = none, experience freedom from headache.

Outcome measures

Measure	Greater Occipital Nerve Block n=13 Participants Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham n=15 Participants Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Number of Participants Who Achieve Freedom From Headache	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Attaining a headache level of "mild" or "none" within one hour of procedure and maintaining this for 48 hours without use of additional medication

Outcome measures

Measure	Greater Occipital Nerve Block n=13 Participants Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham n=15 Participants Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Sustained Headache Relief	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Participants will be asked the following question: Do you want to receive the same procedure the next time you come to the ER with migraine?

Outcome measures

Measure	Greater Occipital Nerve Block n=13 Participants Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham n=15 Participants Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Would Want the Same Treatment Again During a Subsequent Migraine	5 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 minutes

The numerical scale, 0-10 pain scores will be obtained with 0 being "no pain" and 10 being "the worst pain imaginable."

Outcome measures

Measure	Greater Occipital Nerve Block n=13 Participants Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham n=15 Participants Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Change in Pain Score Assessed by Verbal Pain Scale (0-10)	3.3 units on a scale Standard Deviation 2.8	5.5 units on a scale Standard Deviation 2.4

Adverse Events

Greater Occipital Nerve Block

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sham

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	Greater Occipital Nerve Block n=13 participants at risk Bilateral greater occipital nerve block with 3cc of 0.5% bupivacaine, delivered using fan technique Greater occipital nerve block: Bilateral greater occipital nerve block	Sham n=15 participants at risk Bilateral intradermal injection of 0.5cc of 0.5% bupivacaine, delivered superficially to the area overlying the greater occipital nerve Bupivacaine: 0.5 cc of 0.5% bupivacaine injected intradermally
Injury, poisoning and procedural complications injection site reaction	15.4% 2/13 • Number of events 2 • 48 hours	0.00% 0/15 • 48 hours
Musculoskeletal and connective tissue disorders neck pain	7.7% 1/13 • Number of events 1 • 48 hours	6.7% 1/15 • Number of events 1 • 48 hours
Nervous system disorders dizziness	0.00% 0/13 • 48 hours	6.7% 1/15 • Number of events 1 • 48 hours

Additional Information

Benjamin W. Friedman

Montefiore

Phone: 718-920-6626

Email: befriedm@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place