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NCT Number: NCT05009771

Postoperative Pain Management of Caesarean Section

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

MacKay Memorial Hospital Tamsui Branch, New Taipei City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Intravenous patient-control analgesia

Drug

At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.

Other names: IV-PCA

Dinalbuphine sebacate

Drug

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.

Other names: NALDEBAIN

Primary outcomes

  1. Postpartum pain intensity

    Time frame: 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 outcomes

  1. Consumption of analgesics

    Time frame: Within 5 days after delivery

    The mean total consumption of analgesics during the hospital stay after delivery.

  2. Incidence of complications

    Time frame: Up to 5 days after delivery

    the incidence of postoperative complication occurring during hospital stay after delivery, especially the ones related to analgesics.

  3. Ambulation

    Time frame: Up to 5 days after delivery

    The mean length of time between delivery and the first ambulation.

  4. Breastfeeding

    Time frame: 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.

  5. Gastrointestinal function recovery

    Time frame: Up to 5 days after delivery

    The mean length of time between delivery and first soft diet.

  6. Postnatal Depression assessment

    Time frame: 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.

  7. Satisfaction assessed by a four-point scale

    Time frame: 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.

  8. Chronic pain intensity

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-Hsu Wang, M.D.

CONTACT

[email protected]

+886-2-2809-4661 ext. 5504876

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2021
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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