Cesarean Section (MeSH: D002585)NCT07916051
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
A study testing Esketamine, Active TEAS and Normal Saline in people with Cesarean Section (MeSH: D002585) and Postoperative Pain After Cesarean Section, run by Anhui Provincial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section, Enhanced Recovery After Surgery
- What is being tested?
- Esketamine, Active TEAS and Normal Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years. (No upper age limit).
- Primiparous women.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Gestational age between 37 and 42 weeks.
- Scheduled for elective cesarean section under epidural anesthesia.
Who cannot join
- History of allergy or contraindication 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.
About this study
Official title: Effects of Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality in Parturients Undergoing Cesarean Section: a Prospective Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section, Enhanced Recovery After Surgery
- Being tested
- Esketamine, Active TEAS, Normal Saline, Sham TEAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Administered intravenously at a dose of 0.15 mg/kg (diluted in 10 mL normal saline) immediately after umbilical cord clamping.
Active TEASDevice
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).
Normal SalineDrug
10 mL of 0.9% normal saline administered intravenously as a placebo immediately after umbilical cord clamping.
Sham TEASDevice
The TEAS device is applied to the same acupoints but with the electrical current turned off (the light flashes to blind the participant).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Participants receive sham TEAS (device turned off) and an intravenous injection of 10 mL normal saline after umbilical cord clamping. Receives: Drug: Normal Saline; Device: Sham TEAS |
| TEAS Group | Experimental | Participants receive active TEAS at PC6, HT7, and LI4 acupoints, and an intravenous injection of 10 mL normal saline after umbilical cord clamping. Receives: Device: Active TEAS; Drug: Normal Saline |
| Esketamine Group | Experimental | Participants receive sham TEAS and an intravenous injection of 0.15 mg/kg esketamine (diluted in 10 mL normal saline) after umbilical cord clamping. Receives: Drug: Esketamine; Device: Sham TEAS |
| Combined Group | Experimental | Participants receive active TEAS and an intravenous injection of 0.15 mg/kg esketamine (diluted in 10 mL normal saline) after umbilical cord clamping. Receives: Drug: Esketamine; Device: Active TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 1, 2, and 3.
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Intraoperative and postoperative days 1-3 (for maternal outcomes); immediately after delivery (for neonatal outcomes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section (MeSH: D002585)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Juan, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916051
- Sponsor's protocol ID
- 2026KY498
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Hung KC, Kao CL, Ho CN, Hsing CH, Chang YJ, Wang LK, Liao SW, Chen IW. The impact of perioperative ketamine or esketamine on the subjective quality of recovery after surgery: a meta-analysis of randomised controlled trials. Br J Anaesth. 2024 Jun;132(6):1293-1303. doi: 10.1016/j.bja.2024.03.012. Epub 2024 Apr 12.
PubMed 38614917Zhou D, Hu B, He S, Li X, Gong H, Li F, Wang Q. Transcutaneous Electrical Acupoint Stimulation Accelerates the Recovery of Gastrointestinal Function after Cesarean Section: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2018 Nov 13;2018:7341920. doi: 10.1155/2018/7341920. eCollection 2018.
PubMed 30538764Chen HZ, Gao Y, Li KK, An L, Yan J, Li H, Zhang J. Effect of intraoperative injection of esketamine on postoperative analgesia and postoperative rehabilitation after cesarean section. World J Clin Cases. 2024 Oct 6;12(28):6195-6203. doi: 10.12998/wjcc.v12.i28.6195.
PubMed 39371565Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
PubMed 30579408
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality in Parturients Undergoing Cesarean Section: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07916051
- Acronym / sponsor ID
- 2026KY498
- Conditions
- Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Normal Saline, Device: Sham TEASParticipants receive sham TEAS (device turned off) and an intravenous injection of 10 mL normal saline after umbilical cord clamping. |
| TEAS Group | Experimental | Device: Active TEAS, Drug: Normal SalineParticipants receive active TEAS at PC6, HT7, and LI4 acupoints, and an intravenous injection of 10 mL normal saline after umbilical cord clamping. |
| Esketamine Group | Experimental | Drug: Esketamine, Device: Sham TEASParticipants receive sham TEAS and an intravenous injection of 0.15 mg/kg esketamine (diluted in 10 mL normal saline) after umbilical cord clamping. |
| Combined Group | Experimental | Drug: Esketamine, Device: Active TEASParticipants receive active TEAS and an intravenous injection of 0.15 mg/kg esketamine (diluted in 10 mL normal saline) after umbilical cord clamping. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years. (No upper age limit).
- Primiparous women.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Gestational age between 37 and 42 weeks.
- Scheduled for elective cesarean section under epidural anesthesia.
Key exclusion criteria (5 listed)
- History of allergy or contraindication 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineAdministered intravenously at a dose of 0.15 mg/kg (diluted in 10 mL normal saline) immediately after umbilical cord clamping. | Drug | Combined Group, Esketamine Group |
| Active TEASApplied 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). | Device | Combined Group, TEAS Group |
| Normal Saline10 mL of 0.9% normal saline administered intravenously as a placebo immediately after umbilical cord clamping. | Drug | Control Group, TEAS Group |
| Sham TEASThe TEAS device is applied to the same acupoints but with the electrical current turned off (the light flashes to blind the participant). | Device | Control Group, Esketamine Group |
Primary outcome
Quality of Postoperative Recovery
Time frame: Postoperative days 1, 2, and 3.
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.
6 secondary outcomes
Postoperative Pain and Sedation
Time frame: 12, 24, and 48 hours postoperatively (for VAS and PCA); perioperative period (for sedation).
Sleep Quality and Psychological Status
Time frame: 1 month preoperatively, postoperative days 1-2, and 1 month postoperatively.
Perioperative Hemodynamic Parameters
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 frame: From surgery to hospital discharge.
Inflammatory Markers
Time frame: baseline and on postoperative day 2.
Maternal Adverse Events and Neonatal Outcomes
Time frame: Intraoperative and postoperative days 1-3 (for maternal outcomes); immediately after delivery (for neonatal outcomes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 38614917Hung KC, Kao CL, Ho CN, Hsing CH, Chang YJ, Wang LK, Liao SW, Chen IW. The impact of perioperative ketamine or esketamine on the subjective quality of recovery after surgery: a meta-analysis of randomised controlled trials. Br J Anaesth. 2024 Jun;132(6):1293-1303. doi: 10.1016/j.bja.2024.03.012. Epub 2024 Apr 12.
- Results publication: PubMed 30538764Zhou D, Hu B, He S, Li X, Gong H, Li F, Wang Q. Transcutaneous Electrical Acupoint Stimulation Accelerates the Recovery of Gastrointestinal Function after Cesarean Section: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2018 Nov 13;2018:7341920. doi: 10.1155/2018/7341920. eCollection 2018.
- Results publication: PubMed 39371565Chen HZ, Gao Y, Li KK, An L, Yan J, Li H, Zhang J. Effect of intraoperative injection of esketamine on postoperative analgesia and postoperative rehabilitation after cesarean section. World J Clin Cases. 2024 Oct 6;12(28):6195-6203. doi: 10.12998/wjcc.v12.i28.6195.
- Results publication: PubMed 30579408Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine, Active TEAS and Normal Saline in people with Cesarean Section (MeSH: D002585) and Postoperative Pain After Cesarean Section, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Postoperative Recovery (time frame: Postoperative days 1, 2, and 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07916051, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.