Clinical trial

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

Name

21MMHIS203e

Description

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.

Trial arms

Trial start

2022-02-23

Estimated PCD

2024-04-30

Trial end

2024-07-31

Status

Recruiting

Treatment

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.

Arms:

IV-PCA + NALDEBAIN group, IV-PCA group

Other names:

IV-PCA

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.

Arms:

IV-PCA + NALDEBAIN group, NALDEBAIN group

Other names:

NALDEBAIN

Size

150

Primary endpoint

Postpartum pain intensity

Within 5 days after delivery

Eligibility criteria

Inclusion Criteria: 1. Aged 20 to 40. 2. Planing to undergo caesarean section with spinal anesthesia. 3. Scheduled to undergo cesarean section between 37 and 40 weeks of gestation. 4. American Society of Anesthesiology Physical Class 1-2. 5. Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN. Exclusion Criteria: 1. Not willing to provide informed consent. 2. Unable to receive opioids or NSAIDs due to contraindication. 3. Long-term use of opioids or drug abuse. 4. Suffering from chronic pain disease. 5. Having medical history of mental illnesses. 6. Diagnosed with Pre-eclampsia or eclampsia. 7. Diagnosed with gestational diabetes. 8. Unsuitable for participation judged by investigator.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2023-10-23

1 organization

2 products

3 indications

Organization

Mackay Memorial Hospital

Product

Intravenous patient-control analgesia

Indication

Indication

Indication

Product