Postoperative Pain Management of Caesarean Section
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-40
SponsorMackay Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Pregnant woman scheduled to have caesarean section within 30 days.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intravenous patient-control analgesia
DrugAt the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
Dinalbuphine sebacate
DrugDinalbuphine 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: IV-PCA + NALDEBAIN group2 interventions
Group B: IV-PCA group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 5 days after deliverySecondary outcomes
1
Consumption of analgesics
The mean total consumption of analgesics during the hospital stay after delivery.
Time frame
Within 5 days after delivery2
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 delivery3
Ambulation
The mean length of time between delivery and the first ambulation.
Time frame
Up to 5 days after delivery4
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 deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov