PMID- 34124111 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210615 IS - 2296-858X (Print) IS - 2296-858X (Electronic) IS - 2296-858X (Linking) VI - 8 DP - 2021 TI - A Patient-Controlled Intravenous Analgesia With Tramadol Ameliorates Postpartum Depression in High-Risk Woman After Cesarean Section: A Randomized Controlled Trial. PG - 679159 LID - 10.3389/fmed.2021.679159 [doi] LID - 679159 AB - 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). CI - Copyright (c) 2021 Wu, Zhao, Peng, Fang, Ding, Yan, Wang, Zhu, Wang, Li, Chen, Zhang, Deng, Duan, Zuo and Li. FAU - Wu, Zhuoxi AU - Wu Z AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Zhao, Peng AU - Zhao P AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. AD - Department of Anesthesiology, Chinese People's Liberation Army of China (PLA) No. 964 Hospital, Changchun, China. FAU - Peng, Jing AU - Peng J AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Fang, Liang AU - Fang L AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Ding, Jinping AU - Ding J AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Yan, Guangming AU - Yan G AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Wang, Yang AU - Wang Y AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Zhu, Jing AU - Zhu J AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Wang, Dongting AU - Wang D AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Li, Yang AU - Li Y AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Chen, Zhengqiong AU - Chen Z AD - Department of Obstetrics, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Zhang, Qingling AU - Zhang Q AD - Department of Psychology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Deng, Qiangting AU - Deng Q AD - Editorial Office of Journal of Third Military Medical University, Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Duan, Guangyou AU - Duan G AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. FAU - Zuo, Zhiyi AU - Zuo Z AD - Department of Anesthesiology, University of Virginia, Charlottesville, VA, United States. FAU - Li, Hong AU - Li H AD - Department of Anesthesiology, Second Affiliated Hospital of Army Medical University, People's Liberation Army of China (PLA), Chongqing, China. LA - eng SI - ClinicalTrials.gov/NCT03309163 PT - Journal Article DEP - 20210527 PL - Switzerland TA - Front Med (Lausanne) JT - Frontiers in medicine JID - 101648047 PMC - PMC8191376 OTO - NOTNLM OT - PCIA OT - cesarean section OT - perioperative period tramadol PCIA ameliorates PPD 2 OT - postpartum depression OT - tramadol COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/06/15 06:00 MHDA- 2021/06/15 06:01 PMCR- 2021/05/27 CRDT- 2021/06/14 09:51 PHST- 2021/03/11 00:00 [received] PHST- 2021/04/19 00:00 [accepted] PHST- 2021/06/14 09:51 [entrez] PHST- 2021/06/15 06:00 [pubmed] PHST- 2021/06/15 06:01 [medline] PHST- 2021/05/27 00:00 [pmc-release] AID - 10.3389/fmed.2021.679159 [doi] PST - epublish SO - Front Med (Lausanne). 2021 May 27;8:679159. doi: 10.3389/fmed.2021.679159. eCollection 2021.