A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial

Zhuoxi Wu; Peng Zhao; Jing Peng; Liang Fang; Jinping Ding; Guangming Yan; Yang Wang; Jing Zhu; Dongting Wang; Yang Li; Zhengqiong Chen; Qingling Zhang; Qiangting Deng; Guangyou Duan; Zhiyi Zuo; Hong Li

doi:10.3389/fmed.2021.679159

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.

Authors

Zhuoxi Wu¹, Peng Zhao^{1

2}, Jing Peng¹, Liang Fang¹, Jinping Ding¹, Guangming Yan¹, Yang Wang¹, Jing Zhu¹, Dongting Wang¹, Yang Li¹, Zhengqiong Chen³, Qingling Zhang⁴, Qiangting Deng⁵, Guangyou Duan¹, Zhiyi Zuo⁶, Hong Li¹

Affiliations

¹ Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China.
² Department of Anesthesiology, Chinese People's Liberation Army of China (PLA) No. 964 Hospital, Changchun, China.
³ Department of Obstetrics, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China.
⁴ Department of Psychology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China.
⁵ Editorial Office of Journal of Third Military Medical University, Army Medical University, People's Liberation Army of China (PLA), Chongqing, China.
⁶ Department of Anesthesiology, University of Virginia, Charlottesville, VA, United States.

Abstract

Background: Postpartum depression (PPD) is a severe psychiatric disorder. Its risk is associated with the cesarean section (CS). Currently, there are few early intervention strategies for these women with PPD who underwent CS. Methods: This was a parallel-group randomized controlled trial of singleton pregnant women who underwent elective CS in a tertiary referral hospital in China from October, 2017 to September, 2019. After operation, patients received randomly tramadol patient-controlled intravenous analgesia (PCIA; 4 mg/ml; TRA group), hydromorphone PCIA (0.04 mg/ml; HYD group), or ropivacaine patient-controlled epidural analgesia (PCEA; 1.5 mg/ml; ROP group) for 48 h in a 1:1:1 ratio. Total blinding during hospitalization was not feasible due to differences between the PCEA and PCIA treatments. All investigators who performed the follow-up were blinded to the group assignment. Outcomes: A total of 1,230 patients were enrolled for eligibility. Intention-to-treat analysis showed reduced incidence of PPD in the TRA group (n = 27 [6.6%]) than that in the HYD (10.2%, OR 1.62, 95% CI 0.98~2.68; p = 0.059) and ROP groups (10.5%, OR 1.66, 95% CI 1.01~2.75; p = 0.046) at 4 weeks post-operation, however, the difference was not statistically significant (Bonferroni corrected p = 0.118, p = 0.098, respectively). Subgroup analysis in high-risk women (preoperative Edinburgh Postpartum Depression Scale [EPDS] ≥10) showed a significantly lower incidence of PPD in the TRA group (16.5%) than in the HYD (32.6%) and ROP groups (30.9%) (Bonferroni corrected p = 0.022 and p = 0.038, respectively). The per-protocol analysis yielded similar results. Reported adverse events (AEs) were mostly mild. None of the women or infant discontinued treatment due to AEs. Conclusions: Tramadol PCIA after CS in high-risk women can help to reduce the risk of PPD at 4 weeks after elective CS. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03309163?term=ETPPD&draw=2&rank=1; ClinicalTrials.gov (NCT03309163).

Keywords: PCIA; cesarean section; perioperative period tramadol PCIA ameliorates PPD 2; postpartum depression; tramadol.

Associated data

ClinicalTrials.gov/NCT03309163