Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

NCT07145775 | Completed Phase 4 DMC

• 1 other identifier: 2025R0269
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Epidural Analgesia; Labor Pain; Sufentanil; Dexmedetomidine; Esketamine; Ropivacaine

Keywords

epidural anagelsia; labor pain; sufentanil; dexmedetomidine; esketamine; ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of analgesia to 2 hours after childbirth

Secondary Outcomes (4)

• Incidence of a composite of neonatal morbility

  From immediate childbirth to 24 hours after childbirth

• Dosage of epidural labor analgesics

  From start of analgesia to end of third stage or childbirth

• Incidence of persistent pain at 42 days postpartum

  At 42 days postpartum

• Incidence of depression at 42 days postpartum

  At 42 days postpartum

Other Outcomes (7)

• Scores of pain intensity at various timepoints during labor

  Up to 2 hours after childbirth

• Scores of sedation at various timepoints during labor

  Up to 2 hours after childbirth

• Degree of lower limb motor block at various timepoints during labor

  Up to 2 hours after childbirth

Study Arms (3)

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).

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).

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).

Drug: dexmedetomidine-esketamine-ropivacaine combination 2

Interventions

sufentanil-ropivacaine combination DRUG

Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).

Also known as: epidural analgesia using the sufentanil-ropivacaine combination

control group

dexmedetomidine-esketamine-ropivacaine combination 1 DRUG

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).

Also known as: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 1

experimental group 1

dexmedetomidine-esketamine-ropivacaine combination 2 DRUG

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).

Also known as: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 2

experimental group 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women preparing for vaginal delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or above;
• Single term cephalic pregnancy preparing for vaginal delivery;
• Agreed to receive epidural labor analgesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (9)

• 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.

  PMID: 37214452 BACKGROUND

• Zhang 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.

  PMID: 37302963 RESULT

• Li 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.

  PMID: 39773190 RESULT

• Xu 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.

  PMID: 39488417 RESULT

• Richards 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.

  PMID: 39753406 RESULT

• Jin 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.

  PMID: 39806707 RESULT

• Qian 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.

  PMID: 33078536 RESULT

• Rao 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.

  PMID: 33533982 RESULT

• Armstrong 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.

  PMID: 26832926 RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology

Model Details: a randomized, double-blind, pilot trial with three parallel-arms

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: September 5, 2025
• Primary Completion: January 29, 2026
• Study Completion: March 13, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)