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Effect and mechanism of Butorphanol in preventing epidural related maternal fever during labor

Effect and mechanism of Butorphanol in preventing epidural related maternal fever during labor

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057527
Enrollment
Unknown
Registered
2022-03-14
Start date
2022-03-14
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Epidural related maternal fever

Interventions

Butorphanol group:30 minutes after epidural labor analgesia, intravenous butorphanol 1ml (1mg/ml) was administered
Control group:30 minutes after epidural analgesia, 1ml of normal saline was given intravenously

Sponsors

Women' Hosipital of Nanjing Medical University (Nanjing Maternity and Child Health Care Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Classification I-II; 2. Aged 18-40 years; 3. BMI =37 weeks; 5. Parturient parturient with head; 6. Epidural analgesia and dilation of uterine orifice <=3cm; 7. Initial body temperature is normal; 8. No contraindications to epidural anesthesia, no pregnancy-related diseases such as gestational hypertension and gestational diabetes, no infectious diseases (such as hepatitis B and syphilis), no abnormal monitoring of fetal heart rate before labor analgesia (fetal heart rate range 110-160 bpm).

Exclusion criteria

Exclusion criteria: 1. Premature rupture of membranes; 2. Contraindications to intraspinal anesthesia (e.g., abnormal coagulation function, puncture site infection); 3. Those who have known the ingredients of the study drugs or are allergic to other drugs used in the study; 4. Use opioids and other sedative and analgesic drugs, magnesium sulfate, antipyretic and analgesic drugs within one week; 5. Patients with a history of drug abuse; 6. Patients with sleep apnea syndrome; 7. Patients with severe heart, lung, liver and kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
Intrapartum fever rate (T>=37.5?);Determination of cytokines in HUVECs and TBS cells;Determination of cytokines in HUVECs and TBS cells;

Secondary

MeasureTime frame
Maternal temperature;The consumption of ropivacaine hourly;The consumption of opioid drugs;Total comsumption of ropivacaine;Total comsumption of opioid drugs;Duration of rupture;Method of rupture;Number of vaginal examinations;Total comsumption of oxytocin;First duration of labor;Second duration of labor;Third duration of labor;Total duration of labor;Incidence of cesarean section;Incidence of instrumental delivery;Bleeding volume;Incidence of fetal arrhythmia;Neonatal Apgar score (1min);Neonatal Apgar score (5min);Neonatal NICU conversion rate;Incidence of butorphanol related adverse reactions (nausea and vomiting);Serum inflammatory factor concentration;

Countries

China

Contacts

Public ContactLi Caijuan

Women' Hosipital of Nanjing Medical University (Nanjing Maternity and Child Health Care Hospital)

lcj_1228@126.com+86 17372283502

Outcome results

None listed

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