An interventional study of Esketamine and Active TEAS in Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section and Enhanced Recovery After Surgery, sponsored by Anhui Provincial Hospital. Not yet recruiting. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Anhui Provincial Hospital · Not applicable, Interventional, and Treatment
This study is a prospective randomized controlled trial aimed at evaluating whether the combination of esketamine and transcutaneous electrical acupoint stimulation (TEAS) can improve the quality of postoperative recovery in women undergoing elective cesarean section. First-time mothers scheduled for surgery will be randomly assigned to one of four groups: a control group (standard care), a TEAS group, an esketamine group, or a combined group (TEAS plus esketamine). TEAS will be applied to specific acupoints before delivery. Esketamine (0.15 mg/kg) will be administered intravenously immediately after the umbilical cord is clamped to minimize fetal exposure. The primary outcome is the overall quality of recovery, assessed using the ObsQoR-11 scale during the first three days after surgery. We will also evaluate pain levels, sleep quality, anxiety and depression, early recovery milestones, inflammatory responses, adverse reactions, and newborn safety. The results may provide an effective multi-modal strategy to enhance recovery for mothers after a cesarean delivery.
Background and Rationale:
Cesarean section is one of the most common obstetric surgeries globally. Inadequate postoperative pain management can negatively impact maternal sleep, early ambulation, breastfeeding, and increase the risk of postpartum anxiety and depression. Esketamine, an NMDA receptor antagonist, provides effective analgesia, opioid-sparing effects, and mood regulation. Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive neuromodulation technique that exerts analgesic effects through the endogenous opioid system and regulates gastrointestinal function. The clinical benefits of esketamine and TEAS are complementary, suggesting a potential synergistic effect in multimodal analgesia and enhanced recovery after surgery (ERAS).
Specific Study Design Rationale:
The acupoints selected in this trial (PC6, HT7, and LI4) are specifically targeted for their effects on pain relief, anxiolysis, and gastrointestinal motility. A disperse-dense frequency (2/10 Hz) is utilized to prevent nerve adaptation and maximize tolerance. Furthermore, to minimize fetal exposure, esketamine will be administered intravenously only after fetal delivery and umbilical cord clamping.
Significance:
This study aims to translate the theoretical synergistic benefits of these two interventions into clinical evidence. The findings will determine whether this combined strategy offers incremental benefits over single interventions in improving the overall quality of recovery for parturients, thereby providing a robust clinical basis for optimizing multimodal analgesic and ERAS protocols.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 384 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Anhui Provincial Hospital is the lead sponsor of 135 studies on the registry; 101 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Age ≥ 18 years. (No upper age limit).
Primiparous women.
(ASA) physical status I or II.
Gestational age between 37 and 42 weeks.
Scheduled for elective cesarean section under epidural anesthesia.
Exclusion Criteria:
- History of allergy or to esketamine.
Contraindications to neuraxial anesthesia (e.g., coagulopathy).
Severe pregnancy complications (e.g., severe fetal distress, umbilical cord prolapse, placenta previa with massive hemorrhage, placental abruption).
Severe dysfunction of vital organs.
Skin breakdown or infection at the selected acupoint sites.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive sham TEAS (device turned off) and an intravenous injection of 10 mL normal saline after umbilical cord clamping.
Drug: Normal Saline · Device: Sham TEAS
Participants receive active TEAS at PC6, HT7, and LI4 acupoints, and an intravenous injection of 10 mL normal saline after umbilical cord clamping.
Device: Active TEAS · Drug: Normal Saline
Participants receive sham TEAS and an intravenous injection of 0.15 mg/kg esketamine (diluted in 10 mL normal saline) after umbilical cord clamping.
Drug: Esketamine · Device: Sham TEAS
Participants receive active TEAS and an intravenous injection of 0.15 mg/kg esketamine (diluted in 10 mL normal saline) after umbilical cord clamping.
Drug: Esketamine · Device: Active TEAS
Administered intravenously at a dose of 0.15 mg/kg (diluted in 10 mL normal saline) immediately after umbilical cord clamping.
Applied bilaterally at PC6 (Neiguan), HT7 (Shenmen), and LI4 (Hegu) acupoints using a Hwato DZ-III stimulator. Parameters: disperse-dense frequency of 2/10 Hz, intensity adjusted to the maximum tolerable level (6-12 mA).
10 mL of 0.9% normal saline administered intravenously as a placebo immediately after umbilical cord clamping.
The TEAS device is applied to the same acupoints but with the electrical current turned off (the light flashes to blind the participant).
Quality of Postoperative Recovery
Assessed using the ObsQoR-11 (Obstetric Quality of Recovery-11) scale. The score ranges from 0 to 110, with higher scores indicating better quality of recovery.
Time frame: Postoperative days 1, 2, and 3.
Postoperative Pain and Sedation
Visual Analogue Scale (VAS) scores at rest and during movement (0 = no pain, 10 = worst pain); consumption and effective presses of patient-controlled analgesia (PCA); requirement for rescue analgesics (Flurbiprofen axetil); and Ramsay sedation scores.
Time frame: 12, 24, and 48 hours postoperatively (for VAS and PCA); perioperative period (for sedation).
Sleep Quality and Psychological Status
Pittsburgh Sleep Quality Index (PSQI) for preoperative sleep; Leeds Sleep Evaluation Questionnaire (LSEQ) for postoperative sleep; Hospital Anxiety and Depression Scale (HADS); and Edinburgh Postnatal Depression Scale (EPDS).
Time frame: 1 month preoperatively, postoperative days 1-2, and 1 month postoperatively.
Perioperative Hemodynamic Parameters
Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP).
Time frame: Baseline, after block reaches T6-S, skin incision, 1 and 5 minutes after study drug injection, fetal delivery, end of surgery, and 1 and 2 hours postoperatively.
Early Recovery Milestones and Perioperative Data
Time to first flatus, first urination, first ambulation, and urinary catheter removal; length of hospital stay; surgical duration; intraoperative blood loss, urine output, and fluid infusion volume.
Time frame: From surgery to hospital discharge.
Inflammatory Markers
White Blood Cell (WBC) count, Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR).
Time frame: baseline and on postoperative day 2.
Maternal Adverse Events and Neonatal Outcomes
Incidence of maternal adverse reactions (e.g., nausea, vomiting, dizziness, hallucinations, skin allergies, respiratory depression); neonatal Apgar scores at 1 and 5 minutes; umbilical cord blood gas analysis (pH, Base Excess, lactate); and NICU admission rate.
Time frame: Intraoperative and postoperative days 1-3 (for maternal outcomes); immediately after delivery (for neonatal outcomes).
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to patient privacy and ethical restrictions. The data contains sensitive maternal and neonatal health information, and the informed consent obtained from participants does not permit public data sharing.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Esketamine