Protocol for a randomised, double-blind, placebo-controlled trial to explore the effect of tramadol in the prevention of postpartum depression (ETPPD).
INTRODUCTION
Postpartum depression is one of the most commonly experienced psychological disorders for women patients undergoing caesarean section, which accounts for about one-third of puerpera worldwide. Tramadol, a commonly used analgesic with an inhibitory effect on the reuptake of norepinephrine and serotonin, is an effective and well-tolerated agent for analgesia after caesarean section. Based on the role of changes in the postpartum levels of serotonin and norepinephrine in postpartum depression, we speculated that postoperative intravenous analgesia using tramadol may decrease the incidence of postpartum depression for caesarean patients. Therefore, this trial aimed to explore the effect of tramadol in the prevention of postpartum depression.


METHODS AND ANALYSIS
A randomised double-blind placebo-controlled trial will be performed and 1230 singleton parturients will be randomised to receive patient-controlled intravenous analgesia with tramadol or hydromorphone, or patient-controlled epidural analgesia with ropivacaine. The primary outcome of this trial will be the incidence of postpartum depression at 4 weeks after the caesarean section, together with the collection of the relevant data during hospitalisation and at 3 months after the caesarean section. Subgroup data according to the preoperative depression score will be analysed. Demographic characteristics, postoperative analgesic effects and postoperative recovery score will also be summarised and presented.


ETHICS AND DISSEMINATION
The current trial protocol was approved by the Institutional Ethics Committee of Xinqiao Hospital (ID: 2017-026), Third Military Medical University, Chongqing, China. The results of this trial will be disseminated at scientific meetings and in a peer-reviewed journal.


TRIAL REGISTRATION NUMBER
NCT03309163; Pre-results.
['Duan|Guangyou|G|', 'Wu|Zhuoxi|Z|', 'Zhao|Peng|P|', 'Peng|Jing|J|', 'Chen|Zhengqiong|Z|', 'Zhang|Qingling|Q|', 'Xu|Rufu|R|', 'Li|Hong|H|']
D000328:Adult D000701:Analgesics, Opioid D002585:Cesarean Section D019052:Depression, Postpartum D004311:Double-Blind Method D005260:Female D006801:Humans D009638:Norepinephrine D010149:Pain, Postoperative D011247:Pregnancy D016032:Randomized Controlled Trials as Topic D012701:Serotonin D014147:Tramadol D016896:Treatment Outcome
tramadol postpartum depression caesarean section analgesia