Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
aSAH, SAH
Brief summary
The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.
Detailed description
The investigators plan to use gabapentin (GBP), an FDA approved non-narcotic pain medication for neuropathic pain, which is also an alpha-2-delta (A2DR) receptor analogue to reduce the pain and decrease the need for narcotics in patients with aneurysmal subarachnoid hemorrhage (aSAH). GBP has been shown to decrease neuropathic and non-neuropathic pain in a variety of perioperative and postoperative conditions. A2DR affinity also has some neuroprotective effect in animal data. The investigators plan to conduct a prospective, double-blinded, randomized trial to further assess GBP-associated reductions in narcotic use and pain scores compared to the non-GBP (placebo) arm. To accomplish this aim, the investigators plan to randomize 20 aSAH patients with headache to either GBP and standard of care pain treatment versus placebo and standard of care treatment.
Interventions
DRUGGabapentin
Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance. Both groups will receive other standard of care pain medications.
DRUGPlacebo
Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance. Both groups will receive other standard of care pain medications.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA) 3. Have symptomatic headache 4. Able to swallow and verbalize pain score 5. No known allergy to gabapentin or fentanyl 6. Numeric pain score ≥ 5 7. Ability to provide written personal consent
Exclusion criteria
1. Gabapentin use prior to SAH admission 2. Renal failure with creatinine clearance less than 30 mL/min 3. Unable to receive standard of care pain medications 4. Pregnant or breastfeeding patients 5. History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Numeric Pain Score | baseline through day 7 | Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score. |
| Average Narcotic Consumption | baseline through day 7 | The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Control Satisfaction Questionnaire | Day 8 | The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications. | 8 |
| Control Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Gabapentin | Control | Total |
|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 10.2 | 49.8 years STANDARD_DEVIATION 11.6 | 51.3 years STANDARD_DEVIATION 10.6 |
| Chronic Pain | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Average Narcotic Consumption
The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).
Time frame: baseline through day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Average Narcotic Consumption | 19.4 milligrams | Standard Deviation 14.8 |
| Control | Average Narcotic Consumption | 20.2 milligrams | Standard Deviation 13.1 |
p-value: 0.79ANOVA
Primary
Average Numeric Pain Score
Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score.
Time frame: baseline through day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Average Numeric Pain Score | 5.2 score on a scale | Standard Deviation 1.9 |
| Control | Average Numeric Pain Score | 5.8 score on a scale | Standard Deviation 1.5 |
p-value: 0.7t-test, 2 sided
Secondary
Pain Control Satisfaction Questionnaire
The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Pain Control Satisfaction Questionnaire | 14 score on a scale | Standard Deviation 4.1 |
| Control | Pain Control Satisfaction Questionnaire | 12.6 score on a scale | Standard Deviation 2.9 |
p-value: 0.66ANOVA