Menu
Recruiting NCT05009771

Postoperative Pain Management of Caesarean Section

— Observational Postoperative Pain Caesarean Section Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous patient-control analgesia, Dinalbuphine sebacate.
Who it may be relevant to
Registry conditions: Postoperative Pain, Caesarean Section, Analgesia. Basic parameters: 20 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study

Overview

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.

Interventions

  • Drug Intravenous patient-control analgesia
    At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
  • Drug Dinalbuphine sebacate
    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.

Primary outcome measures

  • Postpartum pain intensity [Time frame: Within 5 days after delivery]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 2 centers
  • MacKay Memorial Hospital Tamsui Branch — New Taipei City
  • MacKay Memorial Hospital — Taipei

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. PMID 42036188

Identifiers

NCT: NCT05009771 · 21MMHIS203e

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗