Caesarean Section
Conditions
Brief summary
The incidence of postpartum depression in Europe and the United States is about 10%, while in China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common diseases of perinatal distress, but the current research of high-quality prevention and treatment of postpartum depression is still very lack. The study suggests that the risk of postpartum depression in cesarean delivery is significantly higher than that in vaginal delivery. Therefore, postpartum depression in cesarean delivery may require more attention and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain, and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the potential to reduce depression and anxiety. Therefore, for the analgesic demand and antidepressant demand for maternal who undergoing cesarean section, tramadol may be an optimized and effective analgesic for the prevention and treatment of postpartum depression.
Detailed description
This study was designed according to a prospective, randomized, controlled clinical trial. Randomized subjects were randomly assigned to different analgesic drug-treated groups according to the random number induced by SPSS software. All three analgesic treatments were routinely used for clinical analgesia; Anesthesia, surgery, postoperative treatment are in accordance with clinical practice. The investigators conducted a postoperative questionnaire survey and psychological diagnosis for all patients. And blood sample was collected from patients before and 48 hours after the surgery.
Interventions
DRUGTramadol
Patient-controlled intravenous analgesia with Tramadol
DRUGHydromorphone
Patient-controlled intravenous analgesia with Hydromorphone
Patient-controlled epidural analgesia with Ropivacaine.
Sponsors
Xinqiao Hospital of Chongqing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 20 years old ≤ age ≤ 40 years old; * ASA score I-Ⅱ; * uncomplicated and singleton full-term pregnancy; * voluntarily to receive cesarean section and postoperative controlled analgesia; * consent to participate the study.
Exclusion criteria
* with history of mental disorders or psychotropic substances use; * with history of neurological diseases such as epilepsy * with history of previously known diagnosed depression; * with suicidal ideation or history of suicide; * with history of drug，alcohol or opioid abuse; * with monoamine oxidase (MAO) inhibitor treatment at present or in the past 14 days; * participating in other clinical studies * with severe heart disease, brain disease, liver disease and kidney disease; * be allergic to tramadol or opioids; * with any contraindication for combined spinal epidural anesthesia; * incapable of communication or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postpartum depression | At 4 weeks after the surgery | Diagnosed according to DSM-5 diagnostic criteria for postnatal depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GAD-7 scores | At 4 weeks and 3 months after the surgery | Measured using Generalized Anxiety Disorder Scale |
| QoR-15 scores | 48 hours after the surgery | Measured using Quality of recovery 15 |
| Pain intensity | At 6, 12, 24 and 48 hours after the surgery | Pain VAS at 6, 12, 24 and 48 hours after the surgery |
| Norepinephrine and serotonin levels in the blood | At 48 hours after the surgery | Norepinephrine and serotonin concentration in the blood at 48 hours after the surgery |
| The incidence of postpartum depression | At 3 months after the surgery | Diagnosed according to DSM-5 diagnostic criteria for postnatal depression |
| EPDS scores | At 4 weeks and 3 months after the surgery | Measured using Edinburgh Postnatal Depression Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | At 3 months after the surgery | Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery |
| Early walking time | During hospitalization, an average of 36 hours | The time for patient to independently activity |
| Hospital stays | During hospitalization, an average of 72 hours | The time for patient to stay in hospital after the surgery |
Countries
China
Outcome results
None listed