Postoperative Pain Management of Caesarean Section

Mackay Memorial Hospital

Status: Enrolling

Conditions: Postoperative Pain; Caesarean Section; Analgesia

Treatments: Drug: Intravenous patient-control analgesia; Drug: Dinalbuphine sebacate

Study type: Observational

Funder types: Other

Identifiers

NCT05009771

21MMHIS203e

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

IV-PCA + NALDEBAIN group

Description:

Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group.

Treatment:

Drug: Dinalbuphine sebacate

Drug: Intravenous patient-control analgesia

IV-PCA group

Description:

Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group.

Treatment:

Drug: Intravenous patient-control analgesia