Postoperative PainNCT05009771
Postoperative Pain Management of Caesarean Section
An observational study of Postoperative Pain and Caesarean Section, run by Mackay Memorial Hospital at 2 sites in Taiwan.
Trial summary
Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postoperative Pain, Caesarean Section, Analgesia
- What is being tested?
- Dinalbuphine sebacate
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- 2 sitesTaiwan
- Study dates
- 23 Feb 2022to 31 Aug 2026
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant woman scheduled to have caesarean section within 30 days.
Who may be able to join
- Aged 20 to 40.
- Planing to undergo caesarean section with spinal anesthesia.
- Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
- American Society of Anesthesiology Physical Class 1-2.
- Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.
Who cannot join
- Not willing to provide informed consent.
- Unable to receive opioids or NSAIDs due to contraindication.
- Long-term use of opioids or drug abuse.
- Suffering from chronic pain disease.
- Having medical history of mental illnesses.
- Diagnosed with Pre-eclampsia or eclampsia.
- Diagnosed with gestational diabetes.
- Unsuitable for participation judged by investigator.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
MacKay Memorial Hospital Tamsui Branch
New Taipei City, 251
MacKay Memorial Hospital
Taipei, 104
About this study
Official title: Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study
Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.
Read the detailed description
This is a prospective, observational, cohort study. Patients undergoing elective caesarean section will be invited to the study. The written informed consent will be obtained prior to participation. After getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. Through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. Demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.
- Conditions
- Postoperative Pain, Caesarean Section, Analgesia
- Being tested
- Intravenous patient-control analgesia, Dinalbuphine sebacate
- Keywords
- Postoperative Pain, Caesarean section, Postpartum rehabilitation, Dinalbuphine sebacate, PCA, NALDEBAIN
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous patient-control analgesiaDrug
Also called IV-PCA
At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
Dinalbuphine sebacateDrug
Also called NALDEBAIN
Dinalbuphine sebacate is a prodrug of nalbuphine. With oil-based formulation, the active ingredient releases slowly and the effect lasts longer than nalbuphine. After delivery, a single 150 mg dose of dinalbuphine sebacate is administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| IV-PCA + NALDEBAIN group | Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group. Receives: Drug: Intravenous patient-control analgesia; Drug: Dinalbuphine sebacate | |
| IV-PCA group | Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group. Receives: Drug: Intravenous patient-control analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum pain intensity
Pain intensity is assessed by numerical rating scale (NRS) at least twice daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.
Measured: Within 5 days after delivery
Secondary outcomes (8)
Consumption of analgesics
The mean total consumption of analgesics during the hospital stay after delivery.
Measured: Within 5 days after delivery
Incidence of complications
the incidence of postoperative complication occurring during hospital stay after delivery, especially the ones related to analgesics.
Measured: Up to 5 days after delivery
Ambulation
The mean length of time between delivery and the first ambulation.
Measured: Up to 5 days after delivery
Breastfeeding
The percentage of participants able to breastfeed during hospital stay and the mean length of time between delivery and the first breastfeeding.
Measured: Up to 5 days after delivery
Gastrointestinal function recovery
The mean length of time between delivery and first soft diet.
Measured: Up to 5 days after delivery
Postnatal Depression assessment
Edinburgh Postnatal Depression questionnaire is used to assess patients' postpartum depression. Participants are asked to fill in the questionnaire at baseline (within 30 days prior to delivery), 6 weeks and 3 months after delivery.
Measured: At baseline, 6 weeks and 3 months after delivery
Satisfaction assessed by a four-point scale
Participants are asked to assess the satisfaction toward rate of recovery progress and pain management through 6 questions six weeks after delivery. Each question contain 4 choices: very satisfied, satisfied, dissatisfied and very dissatisfied.
Measured: 6 weeks after delivery
Chronic pain intensity
Chronic pain intensity is assessed by NRS 6 weeks and 3 months after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain).
Measured: 6 weeks and 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start23 Feb 2022
- Primary completion30 Apr 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Hsu Wang, Mackay Memorial Hospital
- Investigators
- Chi-Hsu Wang, M.D., Principal investigator, MacKay Memorial Hospital Tamsui Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009771
- Sponsor's protocol ID
- 21MMHIS203e
- Status last verified
- Nov 2026
- First submitted
- 3 Aug 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hou PH, Chung SM, Huang JY, Hsu YW, Wong CS, Weng CS, Wang CH. Efficacy and safety of extended-release dinalbuphine sebacate in a multimodal analgesic regimen following cesarean section: A prospective observational study. Taiwan J Obstet Gynecol. 2026 May;65(3):538-545. doi: 10.1016/j.tjog.2026.02.003.
PubMed 42036188
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05009771
- Acronym / sponsor ID
- 21MMHIS203e
- Conditions
- Postoperative Pain, Caesarean Section, Analgesia
- Keywords
- Postoperative Pain, Caesarean section, Postpartum rehabilitation, Dinalbuphine sebacate, PCA, NALDEBAIN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 18 Aug 2021 (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.
Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.
Detailed description
This is a prospective, observational, cohort study. Patients undergoing elective caesarean section will be invited to the study. The written informed consent will be obtained prior to participation. After getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. Through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. Demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV-PCA + NALDEBAIN group | – | Drug: Intravenous patient-control analgesia, Drug: Dinalbuphine sebacatePatients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group. |
| IV-PCA group | – | Drug: Intravenous patient-control analgesiaPatients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant woman scheduled to have caesarean section within 30 days.
Key inclusion criteria (5 listed)
- Aged 20 to 40.
- Planing to undergo caesarean section with spinal anesthesia.
- Scheduled to undergo cesarean section between 37 and 40 weeks of gestation.
- American Society of Anesthesiology Physical Class 1-2.
- Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.
Key exclusion criteria (8 listed)
- Not willing to provide informed consent.
- Unable to receive opioids or NSAIDs due to contraindication.
- Long-term use of opioids or drug abuse.
- Suffering from chronic pain disease.
- Having medical history of mental illnesses.
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 |
|---|---|---|
| Intravenous patient-control analgesiaAlso: IV-PCAAt the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days. | Drug | IV-PCA + NALDEBAIN group, IV-PCA group |
| Dinalbuphine sebacateAlso: NALDEBAINDinalbuphine sebacate is a prodrug of nalbuphine. With oil-based formulation, the active ingredient releases slowly and the effect lasts longer than nalbuphine. After delivery, a single 150 mg dose of dinalbuphine sebacate is administered intramuscularly. | Drug | IV-PCA + NALDEBAIN group |
Primary outcome
Postpartum pain intensity
Time frame: Within 5 days after delivery
Pain intensity is assessed by numerical rating scale (NRS) at least twice daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.
8 secondary outcomes
Consumption of analgesics
Time frame: Within 5 days after delivery
Incidence of complications
Time frame: Up to 5 days after delivery
Ambulation
Time frame: Up to 5 days after delivery
Breastfeeding
Time frame: Up to 5 days after delivery
Gastrointestinal function recovery
Time frame: Up to 5 days after delivery
Postnatal Depression assessment
Time frame: At baseline, 6 weeks and 3 months after delivery
Satisfaction assessed by a four-point scale
Time frame: 6 weeks after delivery
Chronic pain intensity
Time frame: 6 weeks and 3 months after delivery
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 6 Nov 2026.
- Results publication: PubMed 42036188Hou PH, Chung SM, Huang JY, Hsu YW, Wong CS, Weng CS, Wang CH. Efficacy and safety of extended-release dinalbuphine sebacate in a multimodal analgesic regimen following cesarean section: A prospective observational study. Taiwan J Obstet Gynecol. 2026 May;65(3):538-545. doi: 10.1016/j.tjog.2026.02.003.
- Published results (Taiwanese Journal of Obstetrics \& Gynecology, 2026)Link provided by the sponsor.
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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.
Chi-Hsu Wang, M.D. principal investigator
MacKay Memorial Hospital Tamsui Branch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Caesarean Section, run by Mackay Memorial Hospital at 2 sites 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 5 inclusion and 8 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Postpartum pain intensity (time frame: Within 5 days after delivery). 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 NCT05009771, 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 6 Nov 2026.