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To compare the equivalent dose of alfentanil and sufentanil analgesic efficacy and adverse effects of 0.075% ropivacaine combined with epidural labor analgesia: a multicenter, randomized, controlled, single-blind trial

To compare the equivalent dose of alfentanil and sufentanil analgesic efficacy and adverse effects of 0.075% ropivacaine combined with epidural labor analgesia: a multicenter, randomized, controlled, single-blind trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072104
Enrollment
Unknown
Registered
2023-06-02
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Epidural labor analgesia

Interventions

The sufentanil group:0.075% ropivacaine +0.2µg/ml Sufentanil was administered
Alfentanil group:0.075% ropivacaine +4 µ G/ml alfentanil

Sponsors

The General Hospital of the PLA Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1) Full term (37 ~ 42 weeks), single fetus, first primiparia, maternal and family members all agreed to labor analgesia and signed informed consent. 2) Age 20-35 years, American Society of Anesthesiologists (ASA) Grade ?, height 150-170cm, body mass index <35kg/m2. 3) There are no contraindications to intraspinal anesthesia, such as coagulopathy, puncture site infection or injury, uncorrected maternal hypovolemia or hypotension, increased intracranial pressure, and severe spinal deformity. 4) The uterine opening was 2~3cm, and the obstetrician and midwife assessed that the uterine contractions were regular and in line with the conditions of natural birth. 5) No gestational diabetes mellitus, preeclampsia or eclampsia, placenta previa, no serious heart, brain, liver, kidney and other diseases, no intrauterine growth retardation or congenital growth abnormalities of the fetus.

Exclusion criteria

Exclusion criteria: 1) The subject cannot cooperate with intraspinal puncture. 2) The visual analog scale (VAS) score and the VAS score before analgesia were less than 6 points. 3) Those who dropped out of the experiment and those whose results were suspicious. 4) Puerpera who converted to cesarean section for various reasons during labor analgesia. 5) Allergies to local anesthetics or opioids. 6) Rapid cervical changes (cervical dilation =5cm) within 45 minutes of epidural analgesia. 7) Opioid analgesia before epidural analgesia.

Design outcomes

Primary

MeasureTime frame
The VAS score was evaluated by blunt acupuncture every 2 minutes within 30 minutes of epidural analgesia, and the median VAS time =3 was calculated;

Secondary

MeasureTime frame
Blood pressure, pulse, respiration, blood oxygen, Bromage score vas score;

Countries

China

Contacts

Public ContactDiao yugang

The General Hospital of the PLA Northern Theater Command

caohuijuan1212@sina.com+86 133 0988 0882

Outcome results

None listed

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