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Study on the Efficacy and Safety of Hydromorphone in Post-Cesarean Section PCIA

Study on the Efficacy and Safety of Hydromorphone in Post-Cesarean Section PCIA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105264
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-08-10
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Term Singleton Pregnancy

Interventions

Hydromorphone group (experimental group) :The experimental group will receive hydromorphone at 0.2 mg/kg combined with palonosetron at 4 µg/kg, diluted with normal saline to a total volume of 150 ml.
sufentanil group (control group):The control group will receive sufentanil at 2 µg/kg combined with palonosetron at 4 µg/kg, diluted with normal saline to a total volume of 150 ml. PCIA settings: back

Sponsors

The First Affiliated Hospital of Anhui University of Science and Technology/Huainan First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Term singleton pregnancy; 2.ASA physical status I–II; 3.signed informed consent; 4.and successful spinal anesthesia.

Exclusion criteria

Exclusion criteria: 1.History of opioid allergy; 2.Presence of severe pregnancy complications (e.g., eclampsia, HELLP syndrome); 3.Long-term use of analgesics before surgery; 4.Communication disorders or history of psychiatric illness; 5.Long-term preoperative use of opioids; 6.History of depression or preoperative Self-Rating Depression Scale (SDS) score >= 50; 7.History of chronic sleep disorders or preoperative Pittsburgh Sleep Quality Index (PSQI) score > 5.

Design outcomes

Primary

MeasureTime frame
Resting VAS score at 6 hours postoperatively;incidence of dizziness and drowsiness within 48 hours after surgery;

Secondary

MeasureTime frame
Changes in resting and dynamic VAS scores at 2, 6, 12, 24, and 48 hours postoperatively;Ramsay sedation scores at 24 and 48 hours postoperatively;Time to first activation of the analgesia pump and total analgesic consumption from the pump;Incidence of adverse events such as nausea, vomiting, pruritus, and respiratory depression;SDS and PSQI scores at baseline (preoperative) and at 24 and 48 hours postoperatively;

Countries

China

Contacts

Public ContactYuanyuan Zhao

The First Affiliated Hospital of Anhui University of Science and Technology / Huainan First People's Hospital

541289680@qq.com+86 158 5543 2002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 26, 2026