Cesarean Section Complications Clinical Trial
— ERASOfficial title:
Towards Enhanced Recovery After Cesarean: Scheduled Post-operative Medication: a Randomized Controlled Trial
Verified date | March 2023 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean delivery is the most common surgical procedure in the United States, representing 31.9% of the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of post-operative care while adjusting to motherhood and completing activities of daily living. Often when they return home, they are also tasked with other domestic roles which compounds the challenge of this post-operative period. With a potential impact just in the US on 1.2 million mothers each year, optimizing post-operative pain management in order to reduce the risk of persistent opioid use represents an urgent unmet public health goal. To this end, there are national efforts to reduce the cesarean rate and optimize post-cesarean pain management (3,4). The majority of efforts in the last few years have focused on home-going medications and alterations in prescription practices. Recent recommendations from the Enhanced Recovery After Surgery Society indicate that patients should receive multi-modal analgesia on a regular basis, along with early post-delivery mobilization (3). However, the efficacy of scheduled non-steroidal anti-inflammatory medications (NSAID) along with acetaminophen in the immediate post-operative period and after going home have not been systematically studied in the cesarean population. We hypothesize that patients who receive scheduled medications in the post-operative period are less likely to require opioids for pain relief both in the hospital and after they return home.
Status | Completed |
Enrollment | 33 |
Est. completion date | March 8, 2023 |
Est. primary completion date | March 8, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Undergoing repeat cesarean delivery - =37 week gestation - attended at least 7 prenatal visits - age =18. Exclusion Criteria: - Non-English speaking, attended < 7 prenatal visits, fetal anomalies or death, inability to ambulate, BMI =45kg/m2 at delivery due to higher risk of regional analgesia complications, placental implantation abnormalities, maternal diabetes due to the risk of wound complications, chorioamnionitis, allergy to study medications, underlying renal or hepatic impairment, opioid use in the last 3 months, chronic controlled substance use, chronic pain disorders, history of narcotic addiction, intraoperative hemorrhage not controlled with medication alone, additional concurrent surgeries other than sterilization procedures and presence of endometriosis noted at time of surgery. Patients will be enrolled and randomized to their respective groups after completion of the surgery, as there may be surgical complications that preclude their final enrollment as described in the exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
United States | University ofOklahoma Health Sciences Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of morphine milligram equivalents used from 25-72 hours post-op | Patient's inpatient chart will be reviewed to calculate the amount of oxycodone the patient used, converted to morphine milligram equivalents and recorded. | 25-72 hours post-op | |
Primary | Patient's morphine milligram equivalent usage from day of discharge to outpatient post-operative visit | The patient will be discharged home with 20 tablets of oxycodone 5mg. When they return to their post-operative visit, we will count the number of tablets left in the pill bottle. A low number of remaining tablets would mean increased medication usage outpatient. | post-discharge day #8-12 | |
Secondary | Patient's pain rating on post-operative day #2 and #3 with and without ambulation | The patient will be asked to rate her pain on post-operative day #2 and #3 with and without ambulation on a scale from 1-10 with 1 representing severe pain and 10 representing well controlled pain. | post-op days #2 and #3 | |
Secondary | Patient's pain satisfaction scale on day of post-operative visit | Patient will be asked to mark on a line how satisfied she is with her pain management outpatient with the left side of the line representing poor satisfaction and the right side of the line representing good satisfaction with pain control. The place she marks on the line will be measured and recorded in centimeters. | 1 day of post-operative visit | |
Secondary | Patient's pain satisfaction scale on day of discharge | Patient will be asked to mark on a line how satisfied she is with her pain management during admission with the left side of the line representing poor satisfaction and the right side of the line representing good satisfaction with pain control. The place she marks on the line will be measured and recorded in centimeters. | 1 day of discharge | |
Secondary | Amount of acetaminophen used on post-operative day #2 and #3 | Chart will be reviewed to calculate the amount of acetaminophen in milligrams the patient required on post-operative day #2 and #3 from 0000 to 2359. | post-operative day #2 and #3 | |
Secondary | Amount of ibuprofen used on post-operative day #2 and #3 | Chart will be reviewed to calculate the amount of ibuprofen in milligrams the patient required on post-operative day #2 and #3 from 0000 to 2359. | post-operative days #2 and #3 | |
Secondary | Amount a patient ambulates on post-operative day #2 and #3 | The patient will be given a fitness tracker after surgery and the number of steps the patient takes on post-operative day #2 and #3 will be recorded from 0000 to 2359. | post-operative day #2 and #3 | |
Secondary | Patient's readiness to be discharged | A validated questionnaire will be administered on post-operative day #2 and #3 by a research nurse assessing the patient's perceived readiness to be discharged home. | post-operative day #2 and #3 | |
Secondary | Patient's ambulation on outpatient day #1-3 | The patient will be given a fitness tracker after surgery and the number of steps the patient takes on outpatient day #1-3 will be recorded daily from 0000 to 2359. | information from outpatient day #1-3 will be recorded at the patient's post-operative visit | |
Secondary | Patient's ambulation on outpatient day #4-5 | The patient will be given a fitness tracker after surgery and the number of steps the patient takes on outpatient day #4-5 will be recorded daily from 0000 to 2359. | information from outpatient day #4-5 will be recorded at the patient's post-operative visit | |
Secondary | Patient's sleep pattern on outpatient night #1-3 | The patient will be given a fitness tracker and asked to wear it while sleeping. The amount of time spent in deep sleep, light sleep, and awake will be recorded in hours and minutes on outpatient night #1-3. | information from outpatient night #1-3 will be recorded at the patient's post-operative | |
Secondary | Patient's sleep pattern on outpatient night #4-5 | The patient will be given a fitness tracker and asked to wear it while sleeping. The amount of time spent in deep sleep, light sleep, and awake will be recorded in hours and minutes on outpatient night #4-5. | information from outpatient night #4-5 will be recorded at the patient's post-operative visit | |
Secondary | Patient's acetaminophen usage from discharge to outpatient post-operative visit | The patient will be discharged home with acetaminophen 500mg. When they return to their post-operative visit, we will count the number of tablets left in the pill bottle. A low number of remaining tablets would mean increased medication usage outpatient. | information will be collected at the outpatient post-operative 1 day visit | |
Secondary | Patient's ibuprofen usage from discharge to outpatient post-operative visit | The patient will be discharged home with ibuprofen 800mg. When they return to their post-operative visit, we will count the number of tablets left in the pill bottle. A low number of remaining tablets would mean increased medication usage outpatient. | information will be collected at the outpatient post-operative 1 day visit | |
Secondary | Patient's pain rating on day of post-operative visit with and without ambulation | The patient will be asked to rate her pain at post-operative day with and without ambulation on a scale from 1-10 with 1 representing severe pain and 10 representing well controlled pain. | 1 day of post-operative visit | |
Secondary | Patient's pain rating at 12 hours post-op | The patient will be asked to rate her pain at 12 hour post-op on a scale from 1-10 with 1 representing severe pain and 10 representing well controlled pain. | 12 hours post-op |
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