Trial Outcomes & Findings for Bupivacaine for Benign Headache in the ED (NCT NCT01785459)

NCT ID: NCT01785459

Last Updated: 2022-07-14

Results Overview

Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: enrollment day
• Results posted on: 2022-07-14

Participant Flow

Participant milestones

Measure	Standard Care intravenous Prochlorperazine Standard Care: 10 mg Intravenous injection of Prochlorperazine	Treatment 0.5% bupivacaine 0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bupivacaine for Benign Headache in the ED

Baseline characteristics by cohort

Measure	Standard Care n=11 Participants intravenous Prochlorperazine Standard Care: 10 mg Intravenous injection of Prochlorperazine	Treatment n=12 Participants 0.5% bupivacaine 0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.	Total n=23 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 10.5 • n=93 Participants	30 years STANDARD_DEVIATION 9.1 • n=4 Participants	32 years STANDARD_DEVIATION 9.7 • n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	6 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized African American	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	11 participants n=93 Participants	12 participants n=4 Participants	23 participants n=27 Participants

PRIMARY outcome

Timeframe: enrollment day

Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision

Outcome measures

Measure	Standard Care n=11 Participants intravenous Prochlorperazine Standard Care: 10 mg Intravenous injection of Prochlorperazine	Treatment n=12 Participants 0.5% bupivacaine 0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Length of Stay	158 minutes Standard Deviation 85.5	131 minutes Standard Deviation 113.5

PRIMARY outcome

Timeframe: 72 hours

Population: See AE results

Subjects will be monitored for both immediate and post discharge complications up to 72 hours after enrollment that include: persistent local pain, bleeding, infection, and inadvertent intravascular injection resulting in seizure or possible cardiovascular collapse.

Outcome measures

Measure	Standard Care n=11 Participants intravenous Prochlorperazine Standard Care: 10 mg Intravenous injection of Prochlorperazine	Treatment n=12 Participants 0.5% bupivacaine 0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Incidence of Immediate and Post-discharge Complications.	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 20 minutes

Symptomatic relief of headache will be measured by:

1. Change from pre-intervention pain using a visual analog scale and ordinal scale:

1. Headache relief

2. Partial headache relief

3. No headache relief

4. Headache worsened

2. Treatment failure, defined as requirement for additional medication administered in the ED due to incomplete pain relief from the paraspinous bupivacaine injections or the initial dose of intravenous prochlorperazine.

3. Repeat visit for headache pain within 72 hour time period, excluding routine follow up care, determined by electronic medical record review and telephone follow up.

Outcome measures

Measure	Standard Care n=11 Participants intravenous Prochlorperazine Standard Care: 10 mg Intravenous injection of Prochlorperazine	Treatment n=12 Participants 0.5% bupivacaine 0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Symptomatic Relief of Headache Headache relief	7 Participants	9 Participants
Symptomatic Relief of Headache Partial headache relief	3 Participants	2 Participants
Symptomatic Relief of Headache No headache relief	1 Participants	0 Participants
Symptomatic Relief of Headache Headache worsened	0 Participants	1 Participants

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment

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	Standard Care n=11 participants at risk intravenous Prochlorperazine Standard Care: 10 mg Intravenous injection of Prochlorperazine	Treatment n=12 participants at risk 0.5% bupivacaine 0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
Injury, poisoning and procedural complications pain with injection	0.00% 0/11 • 72 hours and immediately following injection	16.7% 2/12 • Number of events 2 • 72 hours and immediately following injection
Nervous system disorders Akathesia	9.1% 1/11 • Number of events 1 • 72 hours and immediately following injection	0.00% 0/12 • 72 hours and immediately following injection

Additional Information

Dr. Sean Fox

Carolinas Medical Center

Phone: 704-355-3181

Email: Sean.Fox@atriumhealth.org

Results disclosure agreements

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