Skip to content

Epidural Hydromorphone and Morphine for Postcesarean Delivery Analgesia: Determination of the ED90 Using a Sequential Allocation Biased-Coin Method

Epidural Hydromorphone and Morphine for Postcesarean Delivery Analgesia: Determination of the ED90 Using a Sequential Allocation Biased-Coin Method

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084510
Enrollment
Unknown
Registered
2024-05-18
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Postoperative analgesia after caesarean section

Interventions

Hydromorphone group:Mothers in the hydromorphone group were given an initial epidural dose of 400 ug. When the first woman had good analgesia, a biased coin up/down sequential number was drawn, and th
there was an 8/9 chance that she would be assigned to the group where the dose was kept constant. If maternal analgesia is inadequate, the next higher dose of drug is selected for push. Each dose vari
Morphine group:Mothers in the morphine group were given an initial epidural dose of 2000 ug. When the first woman had good analgesia, a biased coin up/down sequential number was drawn, and there was a

Sponsors

Sichuan Academy of Medical Sciences.Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Cesarean section mothers who are willing to participate in the trial. 2. ASA class I ~ III. 3. Full-term pregnant primigravida (>37 weeks)

Exclusion criteria

Exclusion criteria: 1. Contraindications to combined spinal-epidural anesthesia 2. Allergy to opioids. 3. History of analgesic abuse. 4. Cesarean section operation and other operations (tubal ligation, fibroid removal, etc.). 5. History of nausea and vomiting. 6. History of itching. 7. Change of anaesthesia during the operation 8. Multiple pregnancies and multiple caesarean sections. 9. BMI=40 kg/m^2

Design outcomes

Primary

MeasureTime frame
Hydromorphone ED90;Morphine ED90;

Secondary

MeasureTime frame
VAS scores at 6, 12, and 24 hours postsurgery;Satisfaction with analgesia;Total postoperative opioid consumption;Nausea and vomiting;itching;

Countries

China

Contacts

Public ContactMin Xie

Sichuan Academy of Medical Sciences. Sichuan Provincial People’s Hospital

1239473792@qq.com+86 139 8183 5719

Outcome results

None listed

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