Effects of esketamine on postoperative pain, anxiety, depression, sleep, and inflammation in patients undergoing cesarean section: A randomized controlled trial

Abstract

Postoperative pain is the most notable issue after cesarean section (CS). Contributing factors include hyperalgesia, anxiety, depression, sleep disorders, and inflammation. This study explored the effects of esketamine on pain, hyperalgesia, depression, anxiety, sleep disorders, and inflammation after CS. This randomized, double-blind, controlled trial enrolled single-term pregnant women scheduled for elective CS. Participants were randomly included in the esketamine group (group E: intravenous esketamine 0.5 mg/kg + sufentanil 4 μg/kg followed by patient-controlled intravenous analgesia [PCIA] with esketamine 0.5 mg/kg) or the control group (C: normal saline + sufentanil 4 μg/kg PCIA). The primary outcome was the maximum pain numerical rating scale (NRS) score within 24 h postoperatively. Secondary outcomes included pain NRS scores for moving incision, visceral, and rest incision pain at 0–6 h, 6–12 h and 12–24 h; pressure pain threshold and tolerance at 30 min and 24 h postoperatively; PCIA drug consumption and number of compressions; time to first PCIA compression; serum C-reactive protein (CRP) at 24 h; incidence of drug-related side effects; and rates of anxiety, depression, and sleep disorders on postoperative day 2. Ninety-eight women were randomly included in group E (n=50) or C (n=48). Group E had significantly lower maximum NRS pain scores within 24 h (5 [45] vs. 6 [56], P=0.000) and relieved rest incision, visceral, and moving incision pain at all time points. The PCIA compression was significantly delayed, and CRP levels, as well as the incidence of postoperative depression, anxiety, and sleep disorders, were lower in group E. There were no statistically significant differences in hyperalgesia or side effects. Intravenous esketamine effectively reduces postoperative pain, psychological disorders, and inflammation after CS.

This study was registered in the Chinese Clinical Trial Registry with registration number ChiCTR2300078310.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ChiCTR2300078310

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This randomized, double blind, placebo-controlled trial was approved by the Chongqing University Fuling Hospital ethics committee (2023CDFSFLYYEC-064).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Individual participant data are available from the sponsor upon reasonable request through email

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