Epidural AnalgesiaPhase 4NCT07145775
Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
A Phase 4 study testing sufentanil-ropivacaine combination, dexmedetomidine-esketamine-ropivacaine combination 1 and dexmedetomidine-esketamine-ropivacaine combination 2 in people with Epidural Analgesia and Labor Pain, run by Peking University First Hospital at 1 site in China.
Trial summary
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Analgesia, Labor Pain, Sufentanil
- What is being tested?
- sufentanil-ropivacaine combination, dexmedetomidine-esketamine-ropivacaine combination 1 and dexmedetomidine-esketamine-ropivacaine combination 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 13 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above;
- Single term cephalic pregnancy preparing for vaginal delivery;
- Agreed to receive epidural labor analgesia.
Who cannot join
- History of schizophrenia or epilepsy;
- Presence of contraindications for epidural analgesia, including: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy.
- Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR<60 beats per minute) and second-degree or higher atrioventricular block;
- Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure >180 mmHg) and hyperthyroidism;
- Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification >III;
- Other conditions that are considered unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine Combination for Epidural Labor Analgesia and Neonatal Outcomes: a Pilot Randomized Trial
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.
Read the detailed description
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia.
The investigators hypothesize that the dexmedetomidine-esketamine-ropivacaine combination, by avoiding sufentanil and decreasing ropivacaine concentration, may provide non-inferior analgesia with less harmful effect on neonatal outcomes when compared with the sufentanil-ropivacaine combination. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.
- Conditions
- Epidural Analgesia, Labor Pain, Sufentanil, Dexmedetomidine, Esketamine, Ropivacaine
- Being tested
- sufentanil-ropivacaine combination, dexmedetomidine-esketamine-ropivacaine combination 1, dexmedetomidine-esketamine-ropivacaine combination 2
- Keywords
- epidural anagelsia, labor pain, sufentanil, dexmedetomidine, esketamine, ropivacaine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanil-ropivacaine combinationDrug
Also called epidural analgesia using the sufentanil-ropivacaine combination
Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).
dexmedetomidine-esketamine-ropivacaine combination 1Drug
Also called epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 1
Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine).
dexmedetomidine-esketamine-ropivacaine combination 2Drug
Also called epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 2
Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine).
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Epidural analgesia will be conducted with the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine; 100 microgram sufentanil + 18 ml 1% ropivacaine, diluted with normal saline to 250 ml). Receives: Drug: sufentanil-ropivacaine combination |
| experimental group 1 | Experimental | Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 37.5 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml). Receives: Drug: dexmedetomidine-esketamine-ropivacaine combination 1 |
| experimental group 2 | Experimental | Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 50 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml). Receives: Drug: dexmedetomidine-esketamine-ropivacaine combination 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average score of pain intensity during labor
Pain intensity will be assessed with the numeric rating scale (an 11-point scale where 0=no pain and 10=the worst pain) at the fllowing timepoints: before analgesia, 10 and 30 minutes after loading dose, every hour during labor, full cervical dilation, immedlately after childbirth, and 2 hours after childbirth. Time-weighted average score will be calculated by summarizing the product of time interval between two adjacent pain scores multiplied by the average of corresponding pain scores, and then divided by the duration of epidural analgesia.
Measured: From start of analgesia to 2 hours after childbirth
Secondary outcomes (4)
Incidence of a composite of neonatal morbility
Neonatal morbidity includes occurrence of any of the following events: 1-minute Apgar score <7, 5-minute Apgar score <7, neonatal umbilical artery blood gas PH<7.1, need for immediate assisted ventilation after birth, or admission to the neonatal ward or neonatal intensive care unit within 24 hours after birth.
Measured: From immediate childbirth to 24 hours after childbirth
Dosage of epidural labor analgesics
Including number of demanded boluses, number of delivered boluses, total volume, and hourly volume.
Measured: From start of analgesia to end of third stage or childbirth
Incidence of persistent pain at 42 days postpartum
Defined as a numeric rating scale of pain (an 11-point scale where 0=no pain and 10=the worst pain) at rest of 1 point or higher that persisted since childbirth.
Measured: At 42 days postpartum
Incidence of depression at 42 days postpartum
Depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). An Edinburgh depression score of 10 points or higher indicates presence of depressive symptoms.
Measured: At 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start5 Sep 2025
- Primary completion29 Jan 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- More trials run by Peking University First 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, double-blind, pilot trial with three parallel-arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD,PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145775
- Sponsor's protocol ID
- 2025R0269
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lou S, Du Q, Yu L, Wang Q, Yu J, Mei Z. ED90 of epidural esketamine with 0.075% ropivacaine for labor analgesia in nulliparous parturients: a prospective, randomized and dose-finding study. Front Pharmacol. 2023 May 5;14:1169415. doi: 10.3389/fphar.2023.1169415. eCollection 2023.
PubMed 37214452Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
PubMed 37302963Li K, Chai Z, Deng C, Niu G, Geng X, Zhang Y, Wang Y, Wang T. Effects of epidural esketamine versus sufentanil on labor analgesia and postpartum depression: a retrospective cohort study. BMC Anesthesiol. 2025 Jan 7;25(1):6. doi: 10.1186/s12871-024-02846-6.
PubMed 39773190Xu L, Li S, Zhang C, Zhou Y, Chen X. Esketamine administered epidurally as an adjuvant to epidural ropivacaine for labour analgesia: a prospective, double-blind dose-response study. BMJ Open. 2024 Nov 2;14(11):e071818. doi: 10.1136/bmjopen-2023-071818.
PubMed 39488417Richards ND, Howell SJ, Bellamy MC, Beck J. The diverse effects of ketamine, jack-of-all-trades: a narrative review. Br J Anaesth. 2025 Mar;134(3):649-661. doi: 10.1016/j.bja.2024.11.018. Epub 2025 Jan 2.
PubMed 39753406Jin KX, Deng CM, Ding T, Qu Y, Wang DX. Impact of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal outcomes: a pilot randomised clinical trial. BMJ Open. 2024 Dec 22;14(12):e090208. doi: 10.1136/bmjopen-2024-090208.
PubMed 39806707Qian M, Gao F, Liu J, Xu P. Dexmedetomidine versus fentanyl as adjuvants to ropivacaine for epidural anaesthesia: A systematic review and meta-analysis. Int J Clin Pract. 2021 May;75(5):e13772. doi: 10.1111/ijcp.13772. Epub 2020 Dec 20.
PubMed 33078536Rao S, Rajan N. Dexmedetomidine as an Adjunct for Regional Anesthetic Nerve Blocks. Curr Pain Headache Rep. 2021 Feb 3;25(2):8. doi: 10.1007/s11916-020-00926-z.
PubMed 33533982Armstrong S, Fernando R. Side Effects and Efficacy of Neuraxial Opioids in Pregnant Patients at Delivery: A Comprehensive Review. Drug Saf. 2016 May;39(5):381-99. doi: 10.1007/s40264-015-0386-5.
PubMed 26832926
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine Combination for Epidural Labor Analgesia and Neonatal Outcomes: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07145775
- Acronym / sponsor ID
- 2025R0269
- Conditions
- Epidural Analgesia, Labor Pain, Sufentanil, Dexmedetomidine, Esketamine, Ropivacaine
- Keywords
- epidural anagelsia, labor pain, sufentanil, dexmedetomidine, esketamine, ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 28 Aug 2025 (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.
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.
Detailed description
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia.
The investigators hypothesize that the dexmedetomidine-esketamine-ropivacaine combination, by avoiding sufentanil and decreasing ropivacaine concentration, may provide non-inferior analgesia with less harmful effect on neonatal outcomes when compared with the sufentanil-ropivacaine combination. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- a randomized, double-blind, pilot trial with three parallel-arms
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: sufentanil-ropivacaine combinationEpidural analgesia will be conducted with the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine; 100 microgram sufentanil + 18 ml 1% ropivacaine, diluted with normal saline to 250 ml). |
| experimental group 1 | Experimental | Drug: dexmedetomidine-esketamine-ropivacaine combination 1Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 37.5 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml). |
| experimental group 2 | Experimental | Drug: dexmedetomidine-esketamine-ropivacaine combination 2Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 50 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or above;
- Single term cephalic pregnancy preparing for vaginal delivery;
- Agreed to receive epidural labor analgesia.
Key exclusion criteria (6 listed)
- History of schizophrenia or epilepsy;
- Presence of contraindications for epidural analgesia, including: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy.
- Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR<60 beats per minute) and second-degree or higher atrioventricular block;
- Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure >180 mmHg) and hyperthyroidism;
- Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification >III;
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 |
|---|---|---|
| sufentanil-ropivacaine combinationAlso: epidural analgesia using the sufentanil-ropivacaine combinationEpidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine). | Drug | control group |
| dexmedetomidine-esketamine-ropivacaine combination 1Also: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 1Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine). | Drug | experimental group 1 |
| dexmedetomidine-esketamine-ropivacaine combination 2Also: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 2Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine). | Drug | experimental group 2 |
Primary outcome
Time-weighted average score of pain intensity during labor
Time frame: From start of analgesia to 2 hours after childbirth
Pain intensity will be assessed with the numeric rating scale (an 11-point scale where 0=no pain and 10=the worst pain) at the fllowing timepoints: before analgesia, 10 and 30 minutes after loading dose, every hour during labor, full cervical dilation, immedlately after childbirth, and 2 hours after childbirth. Time-weighted average score will be calculated by summarizing the product of time interval between two adjacent pain scores multiplied by the average of corresponding pain scores, and then divided by the duration of epidural analgesia.
4 secondary outcomes
Incidence of a composite of neonatal morbility
Time frame: From immediate childbirth to 24 hours after childbirth
Dosage of epidural labor analgesics
Time frame: From start of analgesia to end of third stage or childbirth
Incidence of persistent pain at 42 days postpartum
Time frame: At 42 days postpartum
Incidence of depression at 42 days postpartum
Time frame: At 42 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 37214452Lou S, Du Q, Yu L, Wang Q, Yu J, Mei Z. ED90 of epidural esketamine with 0.075% ropivacaine for labor analgesia in nulliparous parturients: a prospective, randomized and dose-finding study. Front Pharmacol. 2023 May 5;14:1169415. doi: 10.3389/fphar.2023.1169415. eCollection 2023.
- Results publication: PubMed 37302963Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
- Results publication: PubMed 39773190Li K, Chai Z, Deng C, Niu G, Geng X, Zhang Y, Wang Y, Wang T. Effects of epidural esketamine versus sufentanil on labor analgesia and postpartum depression: a retrospective cohort study. BMC Anesthesiol. 2025 Jan 7;25(1):6. doi: 10.1186/s12871-024-02846-6.
- Results publication: PubMed 39488417Xu L, Li S, Zhang C, Zhou Y, Chen X. Esketamine administered epidurally as an adjuvant to epidural ropivacaine for labour analgesia: a prospective, double-blind dose-response study. BMJ Open. 2024 Nov 2;14(11):e071818. doi: 10.1136/bmjopen-2023-071818.
- Results publication: PubMed 39753406Richards ND, Howell SJ, Bellamy MC, Beck J. The diverse effects of ketamine, jack-of-all-trades: a narrative review. Br J Anaesth. 2025 Mar;134(3):649-661. doi: 10.1016/j.bja.2024.11.018. Epub 2025 Jan 2.
- Results publication: PubMed 39806707Jin KX, Deng CM, Ding T, Qu Y, Wang DX. Impact of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal outcomes: a pilot randomised clinical trial. BMJ Open. 2024 Dec 22;14(12):e090208. doi: 10.1136/bmjopen-2024-090208.
- Results publication: PubMed 33078536Qian M, Gao F, Liu J, Xu P. Dexmedetomidine versus fentanyl as adjuvants to ropivacaine for epidural anaesthesia: A systematic review and meta-analysis. Int J Clin Pract. 2021 May;75(5):e13772. doi: 10.1111/ijcp.13772. Epub 2020 Dec 20.
- Results publication: PubMed 33533982Rao S, Rajan N. Dexmedetomidine as an Adjunct for Regional Anesthetic Nerve Blocks. Curr Pain Headache Rep. 2021 Feb 3;25(2):8. doi: 10.1007/s11916-020-00926-z.
- Results publication: PubMed 26832926Armstrong S, Fernando R. Side Effects and Efficacy of Neuraxial Opioids in Pregnant Patients at Delivery: A Comprehensive Review. Drug Saf. 2016 May;39(5):381-99. doi: 10.1007/s40264-015-0386-5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dong-Xin Wang, MD,PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sufentanil-ropivacaine combination, dexmedetomidine-esketamine-ropivacaine combination 1 and dexmedetomidine-esketamine-ropivacaine combination 2 in people with Epidural Analgesia and Labor Pain, run by Peking University First Hospital at 1 site in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time-weighted average score of pain intensity during labor (time frame: From start of analgesia to 2 hours after childbirth). 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 NCT07145775, which also lists 9 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 13 Apr 2026.