Trial · NCT01785459
Bupivacaine for Benign Headache in the ED
NCT01785459, Phase 2, Terminated, Wake Forest University Health Sciences; results first posted 2019-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bupivacaine for Benign Headache in the ED. Trials, record NCT01785459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785459
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bupivacaine for Benign Headache in the ED
- NCT number
- NCT01785459
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Benign Headache
- Interventions
- 0.5% bupivacaine, Standard Care
- First posted
- 2013-02-07
- Last updated
- 2022-07-14
- Results first posted
- 2019-04-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Length of Stay | enrollment day | Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision |
| Primary | Incidence of Immediate and Post-discharge Complications. | 72 hours | 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. |
| Secondary | Symptomatic Relief of Headache | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Length of Stay | enrollment day | minutes | MEAN | |
| PRIMARY | Incidence of Immediate and Post-discharge Complications. | 72 hours | See AE results | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Symptomatic Relief of Headache | 20 minutes | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Length of Stay | Standard Care | 158 | Standard Deviation 85.5 | minutes | |
| Length of Stay | Treatment | 131 | Standard Deviation 113.5 | minutes | |
| Incidence of Immediate and Post-discharge Complications. | Standard Care | 1 | Participants | ||
| Incidence of Immediate and Post-discharge Complications. | Treatment | 2 | Participants | ||
| Symptomatic Relief of Headache | Standard Care | Headache relief | 7 | Participants | |
| Symptomatic Relief of Headache | Treatment | Headache relief | 9 | Participants | |
| Symptomatic Relief of Headache | Standard Care | Partial headache relief | 3 | Participants | |
| Symptomatic Relief of Headache | Treatment | Partial headache relief | 2 | Participants | |
| Symptomatic Relief of Headache | Standard Care | No headache relief | 1 | Participants | |
| Symptomatic Relief of Headache | Treatment | No headache relief | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Care | 11 | |
| Overall Study | STARTED | Treatment | 12 | |
| Overall Study | COMPLETED | Standard Care | 11 | |
| Overall Study | COMPLETED | Treatment | 12 | |
| Overall Study | NOT COMPLETED | Standard Care | 0 | |
| Overall Study | NOT COMPLETED | Treatment | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | pain with injection | Injury, poisoning and procedural complications | Standard Care | 0 | 11 | 0 |
| other | pain with injection | Injury, poisoning and procedural complications | Treatment | 2 | 12 | 2 |
| other | Akathesia | Nervous system disorders | Standard Care | 1 | 11 | 1 |
| other | Akathesia | Nervous system disorders | Treatment | 0 | 12 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Care | 0 | 11 |
| Total, all-cause mortality | Treatment | 0 | 12 |
| Total, other adverse events | Standard Care | 1 | 11 |
| Total, other adverse events | Treatment | 2 | 12 |
| Total, serious adverse events | Standard Care | 0 | 11 |
| Total, serious adverse events | Treatment | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment vs Standard Care: Incidence of Immediate and Post-discharge Complications. | Trial comparisons |
| Treatment vs Standard Care: deaths from any cause | Trial comparisons |
| Treatment vs Standard Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01785459
GET https://conductscience.org/api/trials/v1/NCT01785459/registered