Uterine PainNCT03878082
Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain
A study testing Propacetamol 1g, Propacetamol 2g and IVPCA in people with Uterine Pain, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Pain
- What is being tested?
- Propacetamol 1g, Propacetamol 2g and IVPCA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy more than 36 weeks which is expected to receive Caesarean section
- Post Caesarean section woman, age greater than or equal to 20 years old
- ASA physical status class 1 or 2
Who cannot join
- ASA physical status class 3 or above
- Less than 20 years old
- Past caesarean section for longitudinal wounds
- Undergone major abdominal surgery
- Chronic pain
- Allergic to morphine or Propacetamol
Show all 9Show fewer
- Liver dysfunction
- Treatment with anticoagulant
- Emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption
To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption
Read the detailed description
The most common method of pain control after cesarean section is intravenous patient-control analgesia (IVPCA) with morphine. Multimodal analgesia could improve the quality of perioperative pain control and reduceside effects of opioids. Previous researches marked that perioperative pain after cesarean section includes somatic wound pain and visceral uterine contraction pain.
According to Academy of Breastfeeding Medicine, propacetamol is a safe pain-killer for an expectant mother and almost free from breast milk after intravenous injection. This study is a prospective double-blind randomized-controlled trial to evaluate that propacetamol could reduce visceral uterine contraction pain after cesarean section. Post cesarean section women will divide into three groups:
- pain control with IVPCA for 2 days
- pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
- pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
- Conditions
- Uterine Pain
- Being tested
- Propacetamol 1g, Propacetamol 2g, IVPCA
- Keywords
- cesarean section, uterine contraction pain, propacetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propacetamol 1gDrug
Also called Propacetamol 1g + IVPCA
pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
Propacetamol 2gDrug
Also called Propacetamol 2g + IVPCA
pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
IVPCADrug
Also called IVPCA alone
pain control with IVPCA
| Study group | Role | What they receive |
|---|---|---|
| propacetamol 1g | Active comparator | pain control with IVPCA and propacetamol 1g every 6 hours for 2 days Receives: Drug: Propacetamol 1g; Drug: IVPCA |
| propacetamol 2g | Active comparator | pain control with IVPCA and propacetamol 2g every 6 hours for 2 days Receives: Drug: Propacetamol 2g; Drug: IVPCA |
| IVPCA | Placebo comparator | pain control with IVPCA Receives: Drug: IVPCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain assessed by NRS
Change of pain assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers) that best reflects the intensity of the pain
Measured: Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section
Incidence of treatment-relate adverse events
the complications or side effects during intervention, such as nausea/vomiting, skin itching, GI discomfort, urinary retention, and respiratory depression
Measured: Two days after the cesarean section
Opioid consumption
Comparison with the placebo group, the requirement of opoid
Measured: Two days after the cesarean section
Secondary outcomes (1)
Satisfaction assessed by the NRS
Participants' satisfaction about post-operative pain management assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers , dissatisfied -> satisfied) that best reflects the satisfaction.
Measured: Two days after the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start12 Aug 2019
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Chung,Huang, Mackay Memorial Hospital
- Investigators
- Chien-Chung Huang, MD, Study director, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878082
- Sponsor's protocol ID
- 19MMHIS044e
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2019
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.
PubMed 25936786Ortiz MI, Ponce-Monter HA, Mora-Rodriguez JA, Barragan-Ramirez G, Barron-Guerrero BS. Synergistic relaxing effect of the paracetamol and pyrilamine combination in isolated human myometrium. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):22-6. doi: 10.1016/j.ejogrb.2011.02.011. Epub 2011 Mar 24.
PubMed 21439705Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S62-S69. doi: 10.1213/01.ANE.0000177100.08599.C8.
PubMed 16334493
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption
- ClinicalTrials.gov ID
- NCT03878082
- Acronym / sponsor ID
- 19MMHIS044e
- Conditions
- Uterine Pain
- Keywords
- cesarean section, uterine contraction pain, propacetamol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Mar 2019 (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.
To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption
Detailed description
The most common method of pain control after cesarean section is intravenous patient-control analgesia (IVPCA) with morphine. Multimodal analgesia could improve the quality of perioperative pain control and reduceside effects of opioids. Previous researches marked that perioperative pain after cesarean section includes somatic wound pain and visceral uterine contraction pain.
According to Academy of Breastfeeding Medicine, propacetamol is a safe pain-killer for an expectant mother and almost free from breast milk after intravenous injection. This study is a prospective double-blind randomized-controlled trial to evaluate that propacetamol could reduce visceral uterine contraction pain after cesarean section. Post cesarean section women will divide into three groups:
- pain control with IVPCA for 2 days
- pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
- pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propacetamol 1g | Active comparator | Drug: Propacetamol 1g, Drug: IVPCApain control with IVPCA and propacetamol 1g every 6 hours for 2 days |
| propacetamol 2g | Active comparator | Drug: Propacetamol 2g, Drug: IVPCApain control with IVPCA and propacetamol 2g every 6 hours for 2 days |
| IVPCA | Placebo comparator | Drug: IVPCApain control with IVPCA |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnancy more than 36 weeks which is expected to receive Caesarean section
- Post Caesarean section woman, age greater than or equal to 20 years old
- ASA physical status class 1 or 2
Key exclusion criteria (9 listed)
- ASA physical status class 3 or above
- Less than 20 years old
- Past caesarean section for longitudinal wounds
- Undergone major abdominal surgery
- Chronic pain
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 |
|---|---|---|
| Propacetamol 1gAlso: Propacetamol 1g + IVPCApain control with IVPCA and propacetamol 1g every 6 hours for 2 days | Drug | propacetamol 1g |
| Propacetamol 2gAlso: Propacetamol 2g + IVPCApain control with IVPCA and propacetamol 2g every 6 hours for 2 days | Drug | propacetamol 2g |
| IVPCAAlso: IVPCA alonepain control with IVPCA | Drug | IVPCA, propacetamol 1g, propacetamol 2g |
Primary outcome
Change of pain assessed by NRS
Time frame: Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section
Change of pain assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers) that best reflects the intensity of the pain
Incidence of treatment-relate adverse events
Time frame: Two days after the cesarean section
the complications or side effects during intervention, such as nausea/vomiting, skin itching, GI discomfort, urinary retention, and respiratory depression
Opioid consumption
Time frame: Two days after the cesarean section
Comparison with the placebo group, the requirement of opoid
1 secondary outcome
Satisfaction assessed by the NRS
Time frame: Two days after the cesarean section
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 15 Mar 2023.
- Background: PubMed 25936786Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.
- Background: PubMed 21439705Ortiz MI, Ponce-Monter HA, Mora-Rodriguez JA, Barragan-Ramirez G, Barron-Guerrero BS. Synergistic relaxing effect of the paracetamol and pyrilamine combination in isolated human myometrium. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):22-6. doi: 10.1016/j.ejogrb.2011.02.011. Epub 2011 Mar 24.
- Background: PubMed 16334493Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S62-S69. doi: 10.1213/01.ANE.0000177100.08599.C8.
- 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.
Chien-Chung Huang, MD study director
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propacetamol 1g, Propacetamol 2g and IVPCA in people with Uterine Pain, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 9 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 15 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 Taiwan. 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.
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?
Change of pain assessed by NRS (time frame: Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section). The study lists 3 primary outcomes in all. 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 NCT03878082, which also lists 3 linked publications.
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 15 Mar 2023.