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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| IV-PCA group | Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous patient-control analgesia | Drug | At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of analgesics | The mean total consumption of analgesics during the hospital stay after delivery. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Study population is pregnant woman.
Pregnant woman scheduled to have caesarean section within 30 days.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi-Hsu Wang, M.D. | Contact | +886-2-2809-4661 | 5504876 | s871017@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chi-Hsu Wang, M.D. | MacKay Memorial Hospital Tamsui Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MacKay Memorial Hospital Tamsui Branch | Recruiting | New Taipei City | Taiwan | 251 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42036188 | Derived | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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|
| Dinalbuphine sebacate | Drug | 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. |
|
|
| Up to 5 days after delivery |
| Ambulation | The mean length of time between delivery and the first ambulation. | 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. | Up to 5 days after delivery |
| Gastrointestinal function recovery | The mean length of time between delivery and first soft diet. | 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. | 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. | 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). | 6 weeks and 3 months after delivery |
| MacKay Memorial Hospital | Not yet recruiting | Taipei | Taiwan | 104 | Taiwan |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |