Cesarean SectionPhase 4NCT06479122
Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section
A Phase 4 study testing Acetaminophen and Acetaminophen/Ibuprofen in people with Cesarean Section and Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Postoperative Pain
- What is being tested?
- Acetaminophen and Acetaminophen/Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Oct 2024to 25 Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cesarean section
- Gestational age > 37+0 weeks
Who cannot join
- Emergency cesarean section
- Multiple pregnancy (e.g. twins, triplets)
- Body weight < 50 kg
- Preeclampsia
- History of hypersensitivity to acetaminophen or ibuprofen
- History of upper gastrointestinal tract bleeding or gastric ulcer
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- Underlying liver disease
- Underlying kidney disease or GFR < 90 mL/min/1.73m2
- Heart failure or severe hypertension
- History of asthma
- Chronic use of barbital or tricyclic antidepressants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junghwa Seo, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
About this study
Official title: Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.
- Conditions
- Cesarean Section, Postoperative Pain
- Being tested
- Acetaminophen, Acetaminophen/Ibuprofen
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Acetaminophen #1
1g acetaminophen is administered during skin closure (end of operation).
Acetaminophen/IbuprofenDrug
Also called Acetaminophen/Ibuprofen #1
A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation)
AcetaminophenDrug
Also called Acetaminophen #2
1g acetaminophen is administered 6 hours after the first administration.
Acetaminophen/IbuprofenDrug
Also called Acetaminophen/Ibuprofen #2
A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | Not described Receives: Drug: Acetaminophen |
| Acetaminophen/Ibuprofen | Experimental | Not described Receives: Drug: Acetaminophen/Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric QoR-11K score 24 hours after end of surgery
Minimum 0, poor recovery; maximum 110, good recovery
Measured: 24 hours after end of surgery
Secondary outcomes (15)
Numeric rating scale pain score (0-10) 4 hours after end of surgery
0, no pain; 10, worst pain imaginable
Measured: 4 hours after end of surgery
Numeric rating scale pain score (0-10) 8 hours after end of surgery
0, no pain; 10, worst pain imaginable
Measured: 8 hours after end of surgery
Numeric rating scale pain score (0-10) 12 hours after end of surgery
0, no pain; 10, worst pain imaginable
Measured: 12 hours after end of surgery
Numeric rating scale pain score (0-10) 24 h after end of surgery
Measured: 24 h after end of surgery
Numeric rating scale pain score (0-10) 48 hours after end of surgery
0, no pain; 10, worst pain imaginable
Measured: 48 hours after end of surgery
Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery
Measured: 24 h after end of surgery
Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery
Measured: 48 h after end of surgery
Use of rescue analgesia during the first 24 hours after end of surgery
Measured: 24 h after end of surgery
Use of rescue analgesia during the first 48 hours after end of surgery
Measured: 48 h after end of surgery
Wound-related complications during hospital stay, up to 5 days
Measured: From end of surgery to patient discharge, up to 5 days
Operation time
Measured: Duration of operation
Anesthesia time
Measured: Duration of anesthesia
Injection level of intrathecal drug
Measured: After arrival at the operating room
Dosage of intrathecal drug (mg, bupivacaine)
Measured: After arrival at the operating room
Sensory blockade level by time point
Measured: 0, 5, 10 minutes after intrathecal injection and at the end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start9 Oct 2024
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479122
- Sponsor's protocol ID
- 2405-052-1535
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen (Maxigesic®IV) in Multimodal Analgesia After Cesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06479122
- Acronym / sponsor ID
- 2405-052-1535
- Conditions
- Cesarean Section, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 28 Jun 2024 (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.
The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: Acetaminophen |
| Acetaminophen/Ibuprofen | Experimental | Drug: Acetaminophen/Ibuprofen |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective cesarean section
- Gestational age > 37+0 weeks
Key exclusion criteria (11 listed)
- Emergency cesarean section
- Multiple pregnancy (e.g. twins, triplets)
- Body weight < 50 kg
- Preeclampsia
- History of hypersensitivity to acetaminophen or ibuprofen
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 |
|---|---|---|
| AcetaminophenAlso: Acetaminophen #11g acetaminophen is administered during skin closure (end of operation). | Drug | Acetaminophen |
| Acetaminophen/IbuprofenAlso: Acetaminophen/Ibuprofen #1A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered during skin closure (end of operation) | Drug | Acetaminophen/Ibuprofen |
| AcetaminophenAlso: Acetaminophen #21g acetaminophen is administered 6 hours after the first administration. | Drug | Acetaminophen |
| Acetaminophen/IbuprofenAlso: Acetaminophen/Ibuprofen #2A mixture of 1g acetaminophen and 300 mg ibuprofen (Maxigesic®IV) is administered 6 hours after the first administration. | Drug | Acetaminophen/Ibuprofen |
Primary outcome
Obstetric QoR-11K score 24 hours after end of surgery
Time frame: 24 hours after end of surgery
Minimum 0, poor recovery; maximum 110, good recovery
15 secondary outcomes
Numeric rating scale pain score (0-10) 4 hours after end of surgery
Time frame: 4 hours after end of surgery
Numeric rating scale pain score (0-10) 8 hours after end of surgery
Time frame: 8 hours after end of surgery
Numeric rating scale pain score (0-10) 12 hours after end of surgery
Time frame: 12 hours after end of surgery
Numeric rating scale pain score (0-10) 24 h after end of surgery
Time frame: 24 h after end of surgery
Numeric rating scale pain score (0-10) 48 hours after end of surgery
Time frame: 48 hours after end of surgery
Use of patient-controlled analgesia (FTN, micrograms) during the first 24 hours after end of surgery
Time frame: 24 h after end of surgery
Use of patient-controlled analgesia (FTN, micrograms) during the first 48 hours after end of surgery
Time frame: 48 h after end of surgery
Use of rescue analgesia during the first 24 hours after end of surgery
Time frame: 24 h after end of surgery
Use of rescue analgesia during the first 48 hours after end of surgery
Time frame: 48 h after end of surgery
Wound-related complications during hospital stay, up to 5 days
Time frame: From end of surgery to patient discharge, up to 5 days
Operation time
Time frame: Duration of operation
Anesthesia time
Time frame: Duration of anesthesia
Injection level of intrathecal drug
Time frame: After arrival at the operating room
Dosage of intrathecal drug (mg, bupivacaine)
Time frame: After arrival at the operating room
Sensory blockade level by time point
Time frame: 0, 5, 10 minutes after intrathecal injection and at the end of operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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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.
Junghwa Seo, MD, PhD contact
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 Acetaminophen and Acetaminophen/Ibuprofen in people with Cesarean Section and Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. 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 South Korea. 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?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hansol Kim, MD (+82-10-3160-1548, hansolfrkr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric QoR-11K score 24 hours after end of surgery (time frame: 24 hours after end of surgery). 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 4 Jun 2025.