RecruitingNCT05009771

Postoperative Pain Management of Caesarean Section

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


Sponsor

Mackay Memorial Hospital

Enrollment

100 participants

Start Date

Feb 23, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

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Interventions

DRUGIntravenous 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.

DRUGDinalbuphine 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.


Locations(2)

MacKay Memorial Hospital Tamsui Branch

New Taipei City, Taiwan, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan, Taiwan

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NCT05009771


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