Cesarean Section, Pain, Postoperative
Conditions
Keywords
IV Acetaminophen, Cesarean Section, Pain, Postoperative
Brief summary
This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.
Detailed description
See Brief Summary
Interventions
DRUGIV Acetaminophen
1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
DRUGPlacebo
100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Scheduled cesarean section delivery * Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates * Singleton pregnancy * Term delivery (greater than or equal to 37 weeks) * Spinal/epidural anesthesia with epidural analgesia (duramorph) * Use of pfannenstiel incision
Exclusion criteria
* Weight less than 50 kg * Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS) * Multiple gestation pregnancy * Cesarean section for pre-term delivery (less than 37 weeks) * Fetal anomalies * Inability to use epidural duramorph at time of procedure * General anesthesia used * Vertical skin incision * Opioid addiction * Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Oxycodone (mg) | approximately 2 - 7 days | Total oxycodone (mg) for breakthrough pain during inpatient stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Narcotic Associated Side Effects | 2-7 days | Only outcome for nausea/emesis is reported. |
| Length of Stay | 2-7 days | Length of hospital stay (admission to discharge) will be collected. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Ibuprofen During Inpatient Stay | 2-7 days | Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Acetaminophen Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given. | 57 |
| Normal Saline Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given. | 47 |
| Total | 104 |
Baseline characteristics
| Characteristic | IV Acetaminophen | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 6 | 29.6 years STANDARD_DEVIATION 6.1 | 29.6 years STANDARD_DEVIATION 6 |
| Race/Ethnicity, Customized Race African American | 21 Participants | 19 Participants | 40 Participants |
| Race/Ethnicity, Customized Race Multiracial | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 33 Participants | 27 Participants | 60 Participants |
| Region of Enrollment United States | 57 Participants | 47 Participants | 104 Participants |
| Sex: Female, Male Female | 57 Participants | 47 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 65 | 0 / 67 |
| serious Total, serious adverse events | 0 / 65 | 0 / 67 |
Outcome results
Primary
Total Oxycodone (mg)
Total oxycodone (mg) for breakthrough pain during inpatient stay
Time frame: approximately 2 - 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen | Total Oxycodone (mg) | 47.0 mg | Standard Deviation 39.1 |
| Normal Saline | Total Oxycodone (mg) | 65.0 mg | Standard Deviation 46.2 |
Secondary
Length of Stay
Length of hospital stay (admission to discharge) will be collected.
Time frame: 2-7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Acetaminophen | Length of Stay | 78 hours |
| Normal Saline | Length of Stay | 78 hours |
Secondary
Number of Participants With Narcotic Associated Side Effects
Only outcome for nausea/emesis is reported.
Time frame: 2-7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Acetaminophen | Number of Participants With Narcotic Associated Side Effects | 17 Participants |
| Normal Saline | Number of Participants With Narcotic Associated Side Effects | 9 Participants |
Other Pre-specified
Total Amount of Ibuprofen During Inpatient Stay
Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.
Time frame: 2-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen | Total Amount of Ibuprofen During Inpatient Stay | 4786 mg | Standard Deviation 2333 |
| Normal Saline | Total Amount of Ibuprofen During Inpatient Stay | 5260 mg | Standard Deviation 1915 |