Effects of intrathecal fentanyl added to bupivacaine and morphine for cesarean section: a randomized, double-blind, clinical controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021721

Enrollment

Unknown

Registered

2019-03-06

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-07-15

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

Conditions

The anesthesia of cesarean section

Interventions

1:Intrathecal bupivacaine10mg and morphine 100µg for cesarean section

2:Intrathecal fentanyl 5µg added to bupivacaine10mg and morphine 100µg for cesarean section

3:Intrathecal fentanyl 10µg added to bupivacaine10mg and morphine 100µg for cesarean section

4:Intrathecal fentanyl 15µg added to bupivacaine10mg and morphine 100µg for cesarean section

5:Intrathecal fentanyl 20µg added to bupivacaine10mg and morphine 100µg for cesarean section

6:Intrathecal fentanyl 25µg added to bupivacaine10mg and morphine 100µg for cesarean section

Eligibility

Sex/Gender

Female

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Maternal with elective cesarean section, age 20-45 years old, body weight 50-80kg, the heigth 150-170cm, ASA I-II, single, gestational age 37 weeks

Exclusion criteria

Exclusion criteria: (1) Maternal risk factors: morbid obesity, severe preeclampsia, macrosomia, multiple pregnancies, unsafe airway, high risk of surgical delivery, history of anesthesia complications (postpartum neurological dysfunction of lower limbs, etc.; (2) The absolute or relative contraindications of spinal anesthesia: patient refused, puncture site infection, and clotting disease, there is no correct low blood volume and increased intracranial pressure, serious cardiovascular stenosis and allergy to local anesthetics, inadequate recovery drugs or first aid equipment is not available, the patient is not cooperate, always nervous function defect, spinal deformity, or history of spinal surgery, and thrombocytopenia.

Design outcomes

Primary

Measure	Time frame
Effects and side effects of anesthesia;Onset time;The anesthesia level and VAS score of intraoperation;Postoperative VAS score and analgesic drug consumption;	—

Secondary

Measure	Time frame
Blood gas analysis of umbilical cord blood;	—

Countries

China

Contacts

Public ContactYun Xia, Yuantao Li

The Ohio State University College of Medicine

yun.xia@osumc.edu+86 614 293-8487,15013857589

Outcome results

None listed

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