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Effects of epidural analgesia loading dose on PCEA after cesarean section

Open label, randmomized, blank controlled parallel study to determine the effects of epidural analgesia loading dose on PCEA after cesarean section

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009857
Enrollment
Unknown
Registered
2016-11-14
Start date
2016-11-18
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Cesarean Section

Interventions

B:0.9%NS
C:2% Lidocaine Hydrochloride
D:Butorphanol

Sponsors

Renshou Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. voluntarily agreed to participate by giving written informed consent 2. aged between 18 and 35 years old (including the cuoff) when consent 3. single birth and mature birth women 4. ASA score I-II 5. voluntarily accept the randomized treament 6. No contraindications to lumbar hemp or epidural anesthesia 7. Consent or ask for postoperative PCEA analgesia pump installation 8. successful anesthetization, no liquids when pumping back the conduit, without additional local anesthetic to the epidural space during the operation 9. Subject must have adequate hematologic and end organ function as indicated by the following laboratory values: Absolute neutrophil count (ANC) = 2*10^9/L Hemoglobin= 90 g/L Platelets= 100*10^9/L Serum total bilirubin=20umol/L ALT=38mmol/l AST=38mmol/l Serum creatinine (Cr) 44-97umol/L Blood urea nitrogen 2.86-8.20mmol/L 10. Coagulation International Normalized Ratio (INR) 0.86-1.30 Prothrombin Time (PT) = 16.00S Activated Partial Thromboplastin Time (aPTT) =45.00S.

Exclusion criteria

Exclusion criteria: 1. Without the basic examinations before the cesarean section ( including but not limited to blood, urine, chemistry test, ECG and ultrasound); 2. unsuccessful anesthetization (including anesthetization failure, single side anesthetization and high plane anesthetization (T4)); 3. Subject changes to general anesthetization during the cesarean section; 4. Subject receives the extra anesthetic or auxiliary analgesics; 5. Subject has the pregnancy-induced hypertension syndrome; 6. Subject has the pregnancy-induced diabetes; 7. Subject is accompanying the serious heart, lung, liver and kidney disease; 8. Subject needs the opioid to treat the chronic pain; 9. Subject has the drug abuse history; 10. Subject has the history of spinal canal anesthesia; 11. Subject has the food or drug allergy history; 12. Subject has the spine malformation; 13. Subject has the trauma surgery history; 14. Subject has the mental disease history; 15. Other conditions that investigators think should be excluded.

Design outcomes

Primary

MeasureTime frame
Incision pain;uterine contraction pain;Pain;

Secondary

MeasureTime frame
Postoperative sedation effections;Recovery of muscle strength of lower limbs;Recovery of gastrointestinal function;Recovery of Bladder function;Usage of the analgesia pump in numbers;Patient satisfaction of analgesia;

Countries

China

Contacts

Public ContactJian Peng
449668404@qq.com+86 13618199978

Outcome results

None listed

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