Effect of Tramadol in Prevention of Postpartum Depression

NCT ID: NCT03309163

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2019-08-13

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.

Conditions

Caesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group T

All patients receive the patient-controlled intravenous analgesia with Tramadol.

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

Patient-controlled intravenous analgesia with Tramadol

Group H

All patients receive the patient-controlled intravenous analgesia with Hydromorphone.

Group Type: PLACEBO_COMPARATOR

Hydromorphone

Intervention Type: DRUG

Patient-controlled intravenous analgesia with Hydromorphone

Group E

All patients receive the patient-controlled epidural analgesia with Ropivacaine.

Group Type: PLACEBO_COMPARATOR

Ropivacaine (Epidural analgesia)

Intervention Type: DRUG

Patient-controlled epidural analgesia with Ropivacaine.

Interventions

Tramadol

Patient-controlled intravenous analgesia with Tramadol

Intervention Type: DRUG

Hydromorphone

Patient-controlled intravenous analgesia with Hydromorphone

Intervention Type: DRUG

Ropivacaine (Epidural analgesia)

Patient-controlled epidural analgesia with Ropivacaine.

Intervention Type: DRUG

Eligibility 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;
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Hong Li

Director, Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

Locations

Xinqiao Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Countries

China

References

Wu Z, Zhao P, Peng J, Fang L, Ding J, Yan G, Wang Y, Zhu J, Wang D, Li Y, Chen Z, Zhang Q, Deng Q, Duan G, Zuo Z, Li H. A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial. Front Med (Lausanne). 2021 May 27;8:679159. doi: 10.3389/fmed.2021.679159. eCollection 2021.

Reference Type: DERIVED

PMID: 34124111 (View on PubMed)

Duan G, Wu Z, Zhao P, Peng J, Chen Z, Zhang Q, Xu R, Li H. Protocol for a randomised, double-blind, placebo-controlled trial to explore the effect of tramadol in the prevention of postpartum depression (ETPPD). BMJ Open. 2018 Oct 21;8(10):e022538. doi: 10.1136/bmjopen-2018-022538.

Reference Type: DERIVED

PMID: 30344172 (View on PubMed)

Other Identifiers

ETPPD Trail

Identifier Type: -

Identifier Source: org_study_id