NCT05009771

Postoperative Pain Management of Caesarean Section

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Mackay Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Postoperative Pain
• Caesarean Section
• Analgesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-23
• Primary completion: 2026-04-30
• Completion: 2026-07-31
• First posted: 2021-08-18
• Last updated: 2025-05-09

Locations

2 sites across 1 country: Taiwan