Postoperative Pain Management of Caesarean Section: a Prospective, Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Intravenous patient-control analgesia
- Conditions
- Postoperative Pain
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Postpartum pain intensity
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
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.
Investigators
Chi-Hsu Wang
Principal Investigator
Mackay Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •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-
- •Planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of NALDEBAIN.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Intravenous patient-control analgesia
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.
Intervention: Dinalbuphine sebacate
IV-PCA group
Patients receiving intravenous patient-controlled analgesia (IV-PCA) will be allocated to IV-PCA group.
Intervention: Intravenous patient-control analgesia
Outcomes
Primary Outcomes
Postpartum pain intensity
Time Frame: 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 Outcomes
- Consumption of analgesics(Within 5 days after delivery)
- Breastfeeding(Up to 5 days after delivery)
- Satisfaction assessed by a four-point scale(6 weeks after delivery)
- Ambulation(Up to 5 days after delivery)
- Incidence of complications(Up to 5 days after delivery)
- Gastrointestinal function recovery(Up to 5 days after delivery)
- Postnatal Depression assessment(At baseline, 6 weeks and 3 months after delivery)
- Chronic pain intensity(6 weeks and 3 months after delivery)