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.
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
100
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 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.
MacKay Memorial Hospital Tamsui Branch
New Taipei City, Taiwan, Taiwan
RECRUITINGMacKay Memorial Hospital
Taipei, Taiwan, Taiwan
NOT_YET_RECRUITINGPostpartum 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.
Time frame: Within 5 days after delivery
Consumption of analgesics
The mean total consumption of analgesics during the hospital stay after delivery.
Time frame: 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.
Time frame: Up to 5 days after delivery
Ambulation
The mean length of time between delivery and the first ambulation.
Time frame: 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.
Time frame: Up to 5 days after delivery
Gastrointestinal function recovery
The mean length of time between delivery and first soft diet.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 6 weeks and 3 months after delivery
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