Postoperative Pain Management of Caesarean Section

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009771
• Other study ID #: 21MMHIS203e
• Status: Recruiting
• Start date: February 23, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Mackay Memorial Hospital
• Contact: Chi-Hsu Wang, M.D.
• Phone: +886-2-2809-4661
• Email: s871017[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Caesarean Section
• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital Tamsui Branch	New Taipei City
Taiwan	MacKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consumption of analgesics	The mean total consumption of analgesics during the hospital stay after delivery.	Within 5 days after delivery
Secondary	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
Secondary	Ambulation	The mean length of time between delivery and the first ambulation.	Up to 5 days after delivery
Secondary	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
Secondary	Gastrointestinal function recovery	The mean length of time between delivery and first soft diet.	Up to 5 days after delivery
Secondary	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
Secondary	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
Secondary	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