Cesarean Section ComplicationsEarly Phase 1ERASNCT04612920
Towards Enhanced Recovery After Cesarean
A Early Phase 1 study testing Ibuprofen, acetaminophen, oxycodone in people with Cesarean Section Complications, run by University of Oklahoma at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Ibuprofen, acetaminophen, oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2020to 8 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing repeat cesarean delivery
- ≥37 week gestation
- attended at least 7 prenatal visits
- age ≥18.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University ofOklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Towards Enhanced Recovery After Cesarean: Scheduled Post-operative Medication: a Randomized Controlled Trial
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.
Read the detailed description
The proposed study is a pragmatic randomized control trial of post-cesarean pain management techniques with participants allocated in a 1:1 ratio using a random block allocation table using blocks of size 4 and 6. Given the nature of the study, it would be impossible to blind participants and clinicians. Participants will be randomized after completion of the procedure to ensure that patients who have significant surgical complications such as severe hemorrhage or those undergoing hysterectomy are excluded.
All participants will receive intrathecal morphine 150mcg per OU standard of care, with orders for pain management per anesthesia for the first 24 hours with a regular diet, removal of urinary catheter 12-24 hours post-operatively, and abdominal binder placed after surgery. In addition, patients will be provided with a fitness tracker to be worn on their wrist throughout hospitalization and until their post-operative visit. After 24 hours, participants will be assigned to either receive current OU standard of care therapy which includes ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours PRN, and oxycodone five mg every six hours PRN or the study protocol. The study protocol will include scheduled ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight hours, given at the same time, along with oxycodone five mg every six hours PRN for breakthrough pain. Both sets of patients will be provided with 60 pills of acetaminophen 500mg and 30 pills ibuprofen 800mg to take at home, with the study participants receiving instructions to take the medications in a scheduled fashion and the other group in an as needed fashion. Both groups will receive a discharge prescription for 20 pills of oxycodone five mg every 6 hours PRN to be taken for breakthrough pain as needed--current standard at OU. All prescriptions will be delivered to the patient from the pharmacy prior to discharge per our departmental standard. Patient requiring more medications to control pain beyond the randomized approach described above will be treated per the discretion of the attending physician or designee. Patients will be seen for a post-operative care visit on post discharge day 8-12 depending on patient and clinic availability and asked to bring their fitness tracker and medication bottles with them for assessment of steps taken, medication consumed, pain outcomes and satisfaction scores. The Oklahoma PMP Aware system will be accessed to record prescriptions for controlled substances from other providers.
- Conditions
- Cesarean Section Complications
- Being tested
- Ibuprofen, acetaminophen, oxycodone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen, acetaminophen, oxycodoneDrug
The timing of medications is the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants will receive ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight hours, given at the same time, along with oxycodone five mg every six hours PRN for breakthrough pain. Receives: Drug: Ibuprofen, acetaminophen, oxycodone |
| Standard Group | No intervention | Participants will receive current OU standard of care therapy which includes ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours PRN, and oxycodone five mg every six hours PRN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25-72 hours post-op
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.
Measured: post-discharge day #8-12
Secondary outcomes (15)
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.
Measured: post-op days #2 and #3
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.
Measured: 1 day of post-operative visit
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.
Measured: 1 day of discharge
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.
Measured: post-operative day #2 and #3
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.
Measured: post-operative days #2 and #3
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.
Measured: post-operative day #2 and #3
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.
Measured: post-operative day #2 and #3
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.
Measured: information from outpatient day #1-3 will be recorded at the patient's post-operative visit
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.
Measured: information from outpatient day #4-5 will be recorded at the patient's post-operative visit
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.
Measured: information from outpatient night #1-3 will be recorded at the patient's post-operative
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.
Measured: information from outpatient night #4-5 will be recorded at the patient's post-operative visit
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.
Measured: information will be collected at the outpatient post-operative 1 day visit
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.
Measured: information will be collected at the outpatient post-operative 1 day visit
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.
Measured: 1 day of post-operative visit
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.
Measured: 12 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start12 Dec 2020
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavan Parikh, MD, Principal investigator, University of Oklahoma HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612920
- Sponsor's protocol ID
- 12675
- Acronym
- ERAS
- Status last verified
- Mar 2023
- First submitted
- 15 Oct 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Enhanced Recovery After Cesarean: Scheduled Post-operative Medication: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04612920
- Acronym / sponsor ID
- ERAS / 12675
- Conditions
- Cesarean Section Complications
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study is a pragmatic randomized control trial of post-cesarean pain management techniques with participants allocated in a 1:1 ratio using a random block allocation table using blocks of size 4 and 6. Given the nature of the study, it would be impossible to blind participants and clinicians. Participants will be randomized after completion of the procedure to ensure that patients who have significant surgical complications such as severe hemorrhage or those undergoing hysterectomy are excluded.
All participants will receive intrathecal morphine 150mcg per OU standard of care, with orders for pain management per anesthesia for the first 24 hours with a regular diet, removal of urinary catheter 12-24 hours post-operatively, and abdominal binder placed after surgery. In addition, patients will be provided with a fitness tracker to be worn on their wrist throughout hospitalization and until their post-operative visit. After 24 hours, participants will be assigned to either receive current OU standard of care therapy which includes ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours PRN, and oxycodone five mg every six hours PRN or the study protocol. The study protocol will include scheduled ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight hours, given at the same time, along with oxycodone five mg every six hours PRN for breakthrough pain. Both sets of patients will be provided with 60 pills of acetaminophen 500mg and 30 pills ibuprofen 800mg to take at home, with the study participants receiving instructions to take the medications in a scheduled fashion and the other group in an as needed fashion. Both groups will receive a discharge prescription for 20 pills of oxycodone five mg every 6 hours PRN to be taken for breakthrough pain as needed--current standard at OU. All prescriptions will be delivered to the patient from the pharmacy prior to discharge per our departmental standard. Patient requiring more medications to control pain beyond the randomized approach described above will be treated per the discretion of the attending physician or designee. Patients will be seen for a post-operative care visit on post discharge day 8-12 depending on patient and clinic availability and asked to bring their fitness tracker and medication bottles with them for assessment of steps taken, medication consumed, pain outcomes and satisfaction scores. The Oklahoma PMP Aware system will be accessed to record prescriptions for controlled substances from other providers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Ibuprofen, acetaminophen, oxycodoneParticipants will receive ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight hours, given at the same time, along with oxycodone five mg every six hours PRN for breakthrough pain. |
| Standard Group | No intervention | –Participants will receive current OU standard of care therapy which includes ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours PRN, and oxycodone five mg every six hours PRN. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Undergoing repeat cesarean delivery
- ≥37 week gestation
- attended at least 7 prenatal visits
- age ≥18.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen, acetaminophen, oxycodoneThe timing of medications is the intervention. | Drug | Study Group |
Primary outcome
Amount of morphine milligram equivalents used from 25-72 hours post-op
Time frame: 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.
Patient's morphine milligram equivalent usage from day of discharge to outpatient post-operative visit
Time frame: post-discharge day #8-12
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.
15 secondary outcomes
Patient's pain rating on post-operative day #2 and #3 with and without ambulation
Time frame: post-op days #2 and #3
Patient's pain satisfaction scale on day of post-operative visit
Time frame: 1 day of post-operative visit
Patient's pain satisfaction scale on day of discharge
Time frame: 1 day of discharge
Amount of acetaminophen used on post-operative day #2 and #3
Time frame: post-operative day #2 and #3
Amount of ibuprofen used on post-operative day #2 and #3
Time frame: post-operative days #2 and #3
Amount a patient ambulates on post-operative day #2 and #3
Time frame: post-operative day #2 and #3
Patient's readiness to be discharged
Time frame: post-operative day #2 and #3
Patient's ambulation on outpatient day #1-3
Time frame: information from outpatient day #1-3 will be recorded at the patient's post-operative visit
Patient's ambulation on outpatient day #4-5
Time frame: information from outpatient day #4-5 will be recorded at the patient's post-operative visit
Patient's sleep pattern on outpatient night #1-3
Time frame: information from outpatient night #1-3 will be recorded at the patient's post-operative
Patient's sleep pattern on outpatient night #4-5
Time frame: information from outpatient night #4-5 will be recorded at the patient's post-operative visit
Patient's acetaminophen usage from discharge to outpatient post-operative visit
Time frame: information will be collected at the outpatient post-operative 1 day visit
Patient's ibuprofen usage from discharge to outpatient post-operative visit
Time frame: information will be collected at the outpatient post-operative 1 day visit
Patient's pain rating on day of post-operative visit with and without ambulation
Time frame: 1 day of post-operative visit
Patient's pain rating at 12 hours post-op
Time frame: 12 hours post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavan Parikh, MD principal investigator
University of Oklahoma HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ibuprofen, acetaminophen, oxycodone in people with Cesarean Section Complications, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of morphine milligram equivalents used from 25-72 hours post-op (time frame: 25-72 hours post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.