A Phase 4 interventional study of Tramadol and Hydromorphone in Caesarean Section, sponsored by Xinqiao Hospital of Chongqing. Completed at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Xinqiao Hospital of Chongqing · Phase 4, Interventional, and Prevention
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.
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.
Exclusion Criteria:
All patients receive the patient-controlled intravenous analgesia with Tramadol.
Drug: Tramadol
All patients receive the patient-controlled intravenous analgesia with Hydromorphone.
Drug: Hydromorphone
All patients receive the patient-controlled epidural analgesia with Ropivacaine.
Drug: Ropivacaine (Epidural analgesia)
Patient-controlled intravenous analgesia with Tramadol
Patient-controlled intravenous analgesia with Hydromorphone
Patient-controlled epidural analgesia with Ropivacaine.
The incidence of postpartum depression
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Time frame: At 4 weeks after the surgery
The incidence of postpartum depression
Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
Time frame: At 3 months after the surgery
EPDS scores
Measured using Edinburgh Postnatal Depression Scale
Time frame: At 4 weeks and 3 months after the surgery
GAD-7 scores
Measured using Generalized Anxiety Disorder Scale
Time frame: At 4 weeks and 3 months after the surgery
QoR-15 scores
Measured using Quality of recovery 15
Time frame: 48 hours after the surgery
Pain intensity
Pain VAS at 6, 12, 24 and 48 hours after the surgery
Time frame: At 6, 12, 24 and 48 hours after the surgery
Norepinephrine and serotonin levels in the blood
Norepinephrine and serotonin concentration in the blood at 48 hours after the surgery
Time frame: At 48 hours after the surgery
Early walking time
The time for patient to independently activity
Time frame: During hospitalization, an average of 36 hours
Hospital stays
The time for patient to stay in hospital after the surgery
Time frame: During hospitalization, an average of 72 hours
Pain intensity
Postoperative pain intensity that evaluated by questionnaire at 3 months after the surgery
Time frame: At 3 months after the surgery
Plan to share: Undecided
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xinqiao Hospital of Chongqing