Cesarean SectionPhase 4NCT02046382
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief
A Phase 4 study testing IV Acetaminophen in people with Cesarean Section and Pain, Postoperative, run by TriHealth Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Pain, Postoperative
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- General anesthesia used
- Vertical skin incision
- Opioid addiction
- Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
About this study
Official title: Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
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.
Read the detailed description
See Brief Summary
- Conditions
- Cesarean Section, Pain, Postoperative
- Being tested
- IV Acetaminophen, Placebo
- Keywords
- IV Acetaminophen, Cesarean Section, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called Ofirmev
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.
PlaceboDrug
Also called Normal Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Experimental | 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. Receives: Drug: IV Acetaminophen |
| Normal Saline | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Oxycodone (mg)
Total oxycodone (mg) for breakthrough pain during inpatient stay
Measured: approximately 2 - 7 days
Secondary outcomes (2)
Number of Participants With Narcotic Associated Side Effects
Only outcome for nausea/emesis is reported.
Measured: 2-7 days
Length of Stay
Length of hospital stay (admission to discharge) will be collected.
Measured: 2-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Lambers, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046382
- Sponsor's protocol ID
- 13068
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2014
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Altenau B, Crisp CC, Devaiah CG, Lambers DS. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control. Am J Obstet Gynecol. 2017 Sep;217(3):362.e1-362.e6. doi: 10.1016/j.ajog.2017.04.030. Epub 2017 Apr 25.
PubMed 28455085
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
- ClinicalTrials.gov ID
- NCT02046382
- Acronym / sponsor ID
- 13068
- Conditions
- Cesarean Section, Pain, Postoperative
- Keywords
- IV Acetaminophen, Cesarean Section, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Experimental | Drug: IV AcetaminophenSubjects 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. |
| Normal Saline | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| IV AcetaminophenAlso: Ofirmev1000mg 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. | Drug | IV Acetaminophen |
| PlaceboAlso: Normal Saline100 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. | Drug | Normal Saline |
Primary outcome
Total Oxycodone (mg)
Time frame: approximately 2 - 7 days
Total oxycodone (mg) for breakthrough pain during inpatient stay
2 secondary outcomes
Number of Participants With Narcotic Associated Side Effects
Time frame: 2-7 days
Length of Stay
Time frame: 2-7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28455085Altenau B, Crisp CC, Devaiah CG, Lambers DS. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control. Am J Obstet Gynecol. 2017 Sep;217(3):362.e1-362.e6. doi: 10.1016/j.ajog.2017.04.030. Epub 2017 Apr 25.
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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.
Donna Lambers, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Acetaminophen in people with Cesarean Section and Pain, Postoperative, run by TriHealth Inc. 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 7 inclusion and 10 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 16 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Oxycodone (mg) (time frame: approximately 2 - 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02046382, which also lists 1 linked publication.
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 16 Aug 2018.