Postoperative Pain Management of Caesarean Section

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Caesarean Section; Analgesia
• Intervention / Treatment: Drug: Intravenous patient-control analgesia; Drug: Dinalbuphine sebacate

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Chi-Hsu Wang, M.D.; Phone Number: 5504876 +886-2-2809-4661; Email: s871017@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 251
    • Recruiting
    • MacKay Memorial Hospital Tamsui Branch
    • Contact: Chi-Hsu Wang, M.D.; Phone Number: 5504876 +886-2-2809-4661; Email: s871017@gmail.com
    • Principal Investigator: Chi-Hsu Wang, M.D.
    • Sub-Investigator: Kuo-Ting Huang, M.D.
  • Taipei, Taiwan, 104
    • Not yet recruiting
    • Mackay Memorial Hospital
    • Contact: Cheng-Yeon Teong, M.D.; Phone Number: 5504805 +886-2-2543-3535; Email: luckystar1987@hotmail.com
    • Sub-Investigator: Cheng-Yeon Teong, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant woman scheduled to have caesarean section within 30 days.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IV-PCA group; Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group.	Drug: Intravenous 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.; Other Names: IV-PCA
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; 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; Drug: Dinalbuphine 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.; Other Names: NALDEBAIN
NALDEBAIN group; Patients injected with dinalbuphine sebacate intramuscularly will be allocated to NALDEBAIN group.	Drug: Dinalbuphine 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.; Other Names: NALDEBAIN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of analgesics	The mean total consumption of analgesics during the hospital stay after delivery.	Within 5 days after delivery
Incidence of complications	the incidence of postoperative complication occurring during hospital stay after delivery, especially the ones related to analgesics.	Up to 5 days after delivery
Ambulation	The mean length of time between delivery and the first ambulation.	Up to 5 days after delivery
Breastfeeding	The percentage of participants able to breastfeed during hospital stay and the mean length of time between delivery and the first breastfeeding.	Up to 5 days after delivery
Gastrointestinal function recovery	The mean length of time between delivery and first soft diet.	Up to 5 days after delivery
Postnatal Depression assessment	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.	At baseline, 6 weeks and 3 months after delivery
Satisfaction assessed by a four-point scale	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.	6 weeks after delivery
Chronic pain intensity	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).	6 weeks and 3 months after delivery

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Chi-Hsu Wang, M.D., MacKay Memorial Hospital Tamsui Branch

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Pain; Caesarean section; Postpartum rehabilitation; Dinalbuphine sebacate; PCA; NALDEBAIN
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 21MMHIS203e

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No