Postoperative Pain Management of Caesarean Section

Recruiting

• Conditions: Postoperative Pain; Caesarean Section; Analgesia
• Interventions: Drug: Intravenous patient-control analgesia; Drug: Dinalbuphine sebacate

• Registration Number: NCT05009771
• Lead Sponsor: Mackay Memorial Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-18
• Study Start: 2022-02-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IV-PCA + NALDEBAIN group	Intravenous patient-control analgesia	Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group.
IV-PCA + NALDEBAIN group	Dinalbuphine sebacate	Patients treated with the combination of IV-PCA and intramuscular injection of dinalbuphine sebacate will be allocated to IV-PCA + NALDEBAIN group.
IV-PCA group	Intravenous patient-control analgesia	Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group.

Primary Outcome Measures

Name	Time	Method
Postpartum pain intensity	Within 5 days after delivery	Pain intensity is assessed by numerical rating scale (NRS) at least twice daily during hospital stay after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain). The area under the curve of NRS are calculated.

Secondary Outcome Measures

Name	Time	Method
Consumption of analgesics	Within 5 days after delivery	The mean total consumption of analgesics during the hospital stay after delivery.
Breastfeeding	Up to 5 days after delivery	The percentage of participants able to breastfeed during hospital stay and the mean length of time between delivery and the first breastfeeding.
Satisfaction assessed by a four-point scale	6 weeks after delivery	Participants are asked to assess the satisfaction toward rate of recovery progress and pain management through 6 questions six weeks after delivery. Each question contain 4 choices: very satisfied, satisfied, dissatisfied and very dissatisfied.
Incidence of complications	Up to 5 days after delivery	the incidence of postoperative complication occurring during hospital stay after delivery, especially the ones related to analgesics.
Ambulation	Up to 5 days after delivery	The mean length of time between delivery and the first ambulation.
Gastrointestinal function recovery	Up to 5 days after delivery	The mean length of time between delivery and first soft diet.
Postnatal Depression assessment	At baseline, 6 weeks and 3 months after delivery	Edinburgh Postnatal Depression questionnaire is used to assess patients' postpartum depression. Participants are asked to fill in the questionnaire at baseline (within 30 days prior to delivery), 6 weeks and 3 months after delivery.
Chronic pain intensity	6 weeks and 3 months after delivery	Chronic pain intensity is assessed by NRS 6 weeks and 3 months after delivery. NRS is a 11-point scale which labeled from zero (no pain) to ten (worst pain).

Trial Locations

Locations (2)

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan

MacKay Memorial Hospital Tamsui Branch; 🇨🇳 New Taipei City, Taiwan