ETPPD: Effect of Tramadol in Prevention of Postpartum Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group T All patients receive the patient-controlled intravenous analgesia with Tramadol. |
Drug: Tramadol
Patient-controlled intravenous analgesia with Tramadol
|
| Placebo Comparator: Group H All patients receive the patient-controlled intravenous analgesia with Hydromorphone. |
Drug: Hydromorphone
Patient-controlled intravenous analgesia with Hydromorphone
|
| Placebo Comparator: Group E All patients receive the patient-controlled epidural analgesia with Ropivacaine. |
Drug: Ropivacaine (Epidural analgesia)
Patient-controlled epidural analgesia with Ropivacaine.
|
Outcome Measures
Primary Outcome Measures
- The incidence of postpartum depression [At 4 weeks after the surgery]
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Secondary Outcome Measures
- 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
- 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
Other Outcome Measures
- 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
- Pain intensity [At 3 months after the surgery]
Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery
Eligibility Criteria
Criteria
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;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xinqiao Hospital, Third Military Medical University | Chongqing | Chongqing | China | 400037 |
Sponsors and Collaborators
- Xinqiao Hospital of Chongqing
Investigators
- Principal Investigator: Hong Li, M.D., Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ETPPD Trail