Postoperative Pain Management of Caesarean Section

NCT05009771 | Recruiting

• 1 other identifier: 21MMHIS203e
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Pain; Caesarean Section; Analgesia

Keywords

Postoperative Pain; Caesarean section; Postpartum rehabilitation; Dinalbuphine sebacate; PCA; NALDEBAIN

Outcome Measures

Primary Outcomes (1)

• Postpartum pain intensity

  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.

  Within 5 days after delivery

Secondary Outcomes (8)

• Consumption of analgesics

  Within 5 days after delivery

• Incidence of complications

  Up to 5 days after delivery

• Ambulation

  Up to 5 days after delivery

• Breastfeeding

  Up to 5 days after delivery

• Gastrointestinal function recovery

  Up to 5 days after delivery

Study Arms (2)

IV-PCA + NALDEBAIN group

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

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

IV-PCA group

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

Drug: Intravenous patient-control analgesia

Interventions

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.

Also known as: IV-PCA

IV-PCA + NALDEBAIN group; IV-PCA group

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.

Also known as: NALDEBAIN

IV-PCA + NALDEBAIN group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Study population is pregnant woman.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant woman scheduled to have caesarean section within 30 days.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (2)

MacKay Memorial Hospital Tamsui Branch

New Taipei City, Taiwan, 251, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan, 104, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Chi-Hsu Wang, M.D.

  MacKay Memorial Hospital Tamsui Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Hsu Wang, M.D.

CONTACT

+886-2-2809-4661; s871017@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 18, 2021
• Study Start: February 23, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)