Postoperative Pain
Conditions
Brief summary
The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.
Detailed description
This is a randomized, placebo controlled, double blind study. After consent, the subject will complete a Depression Screening to establish a baseline score. Within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin) or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have the option to take routine opioid pain medication if her pain is uncontrolled. She will be asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. The subject will complete the Depression Scale again at 48 hours following delivery. At one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a Depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.
Interventions
DRUGGabapentin 600mg
Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
DRUGPlacebo oral capsule
Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women at least 18 years of age 2. Gestational age \> or = to 30 weeks 3. Singleton gestation 4. Women undergoing a non-emergent cesarean delivery 5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean 6. Ability to undergo the informed consent process in English
Exclusion criteria
1. Vertical skin incision 2. General anesthesia for cesarean 3. History of major depression or postpartum depression requiring medication 4. Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia. 5. Magnesium sulfate treatment postpartum 6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine milligram equivalents consumed in the first 48 hours postoperatively | 48 hours | The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine milligram equivalents from hospital discharge to one week postoperatively | one week | The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms. |
| Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively | 48 hours | Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively. |
| Number and type of adverse events potentially associated with study drug (Safety and Tolerability) | one week | Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded |
Outcome results
None listed