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Determination of the Optimal Volume of Programmed Intermittent Epidural Bolus for Labor Analgesia using 45min-fixed Interval, Ropivacaine 0.0625% with Dexmedetomidine 0.4 µg/mL

Determination of the Optimal Volume of Programmed Intermittent Epidural Bolus for Labor Analgesia using 45min-fixed Interval, Ropivacaine 0.0625% with Dexmedetomidine 0.4 µg/mL

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081436
Enrollment
Unknown
Registered
2024-03-01
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural labor analgesia

Interventions

0.0625% Ropivacaine +0.4µg/ml dexmedetomidine with a fixed time interval of 45 minute 6ml group:Injection volume 6ml
0.0625% Ropivacaine +0.4µg/ml dexmedetomidine with a fixed time interval of 45 minute 8ml group:Injection volume 8ml
0.0625% Ropivacaine +0.4µg/ml dexmedetomidine with a fixed time interval of 45 minute 10ml group:Injection volume 10ml
0.0625% Ropivacaine +0.4µg/ml dexmedetomidine with a fixed time interval of 45 minute 12ml group:Injection volume 12ml

Sponsors

Zhejiang Xiaoshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) women between the ages of 18 and 40; (2) ASA 2-3 level; (3) gestational age =37 weeks; (4) Cervical dilation 5 (0= no pain, 10= most pain).

Exclusion criteria

Exclusion criteria: (1) intraspinal anesthesia contraindications; (2) Allergic to local anesthetics or dexmedetomidine; (3) bradycardia; (4) refuse to sign the informed consent; (5) Other conditions: history of cesarean section, long-term use of sedatives or analgesics.

Design outcomes

Primary

MeasureTime frame
Effective rate for each volume group (6,8,10 or 12ml group).;

Secondary

MeasureTime frame
Each stage of labor time;The use of analgesic pump drugs and the number of patient-controlled compressions;Basic information of maternity;NRS (before analgesia, 30min, 60min, complete uterine opening, fetal delivery).;The basic vital signs and sensory motor block scores of the parturients;Mode of delivery;Side effect;Neonatal Apgar score;

Countries

China

Contacts

Public ContactZhong Mei

Zhejiang Xiaoshan Hospital

meizhong@zju.edu.cn+86 189 6997 9723

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026