Effect of Tramadol in Prevention of Postpartum Depression

Phase 4

Completed

• Conditions: Caesarean Section
• Interventions: Drug: Ropivacaine (Epidural analgesia); Drug: Tramadol; Drug: Hydromorphone

• Registration Number: NCT03309163
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Study Timeline

• Study First Submitted: 2017-09-28
• Study Start: 2017-10-09
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-13
• Primary Completion: 2019-06-13
• Status Verified: 2019-08
• Study Completion: 2019-08-13
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Ropivacaine (Epidural analgesia)	All patients receive the patient-controlled epidural analgesia with Ropivacaine.
Group T	Tramadol	All patients receive the patient-controlled intravenous analgesia with Tramadol.
Group H	Hydromorphone	All patients receive the patient-controlled intravenous analgesia with Hydromorphone.

Primary Outcome Measures

Name	Time	Method
The incidence of postpartum depression	At 4 weeks after the surgery	Diagnosed according to DSM-5 diagnostic criteria for postnatal depression

Secondary Outcome Measures

Name	Time	Method
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
EPDS scores	At 4 weeks and 3 months after the surgery	Measured using Edinburgh Postnatal Depression Scale
The incidence of postpartum depression	At 3 months after the surgery	Diagnosed according to DSM-5 diagnostic criteria for postnatal depression
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

Trial Locations

Locations (1)

Xinqiao Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China