Postoperative Pain Management of Caesarean Section

Sponsor

Mackay Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05009771

Collaborator

(none)

150

Enrollment

Locations

5.2

Anticipated Duration (Months)

Patients Per Site

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Caesarean Section Analgesia	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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 23, 2022

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	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

Arm

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

Other Names:

NALDEBAIN

Outcome Measures

Primary Outcome Measures

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

Consumption of analgesics [Within 5 days after delivery]
The mean total consumption of analgesics during the hospital stay after delivery.
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.
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.
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.
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.