Trial Outcomes & Findings for Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients (NCT NCT03435185)

NCT ID: NCT03435185

Last Updated: 2022-03-23

Results Overview

Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: Patients were followed up from baseline to 2 months after first injection.
• Results posted on: 2022-03-23

Participant Flow

16 patients were excluded due to not meeting inclusion criteria

Participant milestones

Measure	Blockade Group Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.	Placebo Group Grater occipital nerve and supraorbital nerve injections with saline Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
Overall Study STARTED	44	43
Overall Study COMPLETED	43	28
Overall Study NOT COMPLETED	1	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Blockade Group n=44 Participants Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.	Placebo Group n=43 Participants Grater occipital nerve and supraorbital nerve injections with saline Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=44 Participants	43 Participants n=43 Participants	87 Participants n=87 Participants
Age, Categorical >=65 years	0 Participants n=44 Participants	0 Participants n=43 Participants	0 Participants n=87 Participants
Sex: Female, Male Female	36 Participants n=44 Participants	37 Participants n=43 Participants	73 Participants n=87 Participants
Sex: Female, Male Male	8 Participants n=44 Participants	6 Participants n=43 Participants	14 Participants n=87 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	44 Participants n=44 Participants	43 Participants n=43 Participants	87 Participants n=87 Participants

PRIMARY outcome

Timeframe: Patients were followed up from baseline to 2 months after first injection.

Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.

Outcome measures

Measure	Blockade Group n=43 Participants Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.	Placebo Group n=28 Participants Grater occipital nerve and supraorbital nerve injections with saline Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
Change of Frequency of Headache	5.3 score on a scale Standard Deviation 7.4	7.5 score on a scale Standard Deviation 7.2

PRIMARY outcome

Timeframe: Patients were followed up for 2 months from baseline after first injection.

Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome

Outcome measures

Measure	Blockade Group n=43 Participants Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.	Placebo Group n=28 Participants Grater occipital nerve and supraorbital nerve injections with saline Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
Change of Severity of Headache	5.5 score on a scale Standard Deviation 1.9	7.4 score on a scale Standard Deviation 1.3

Adverse Events

Blockade Group

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Blockade Group n=43 participants at risk Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.	Placebo Group n=28 participants at risk Grater occipital nerve and supraorbital nerve injections with saline Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
Skin and subcutaneous tissue disorders Minor Bleedings	86.0% 37/43 • 10 months Clinically observed adverse events	67.9% 19/28 • 10 months Clinically observed adverse events

Additional Information

Dr. Cem Bölük

University of Health Sciences Dr. Lütfi Kırdar Kartal Training and Research Hospital

Phone: +902164413900

Email: cem.boluk@sbu.edu.tr

Results disclosure agreements

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