Status:
COMPLETED
Comparison of Two Analgesic Strategies After Scheduled Caesarean
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions:
Analgesia
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.
Detailed Description
Interventional, comparative, randomized, controlled study versus reference therapeutic strategy, in 2 parallel groups, double-blind (patient and evaluator), single-center, aiming to demonstrate the su...
Eligibility Criteria
Inclusion
- Patient to undergo a scheduled caesarean under spinal anesthesia, for the birth of a term baby with a Pfannenstiel-type incision;
- Patient in good health ;
- Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.
Exclusion
- Pregnancy less than 37 weeks with amenorrhea;
- Multiple pregnancy;
- Fetal pathology known at the time of inclusion;
- Body mass index\> 45 kg / m²;
- History of scoliosis or spine surgery;
- History of chronic pain associated with taking opiates, neuropathic pain, neurological pathology;
- Preoperative anemia (blood hemoglobin \<9 g / dL);
- Hypersensitivity to ropivacaine or other local anesthetics with amide bond;
- Hypersensitivity to morphine or opioids;
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04755712
Start Date
March 22 2021
End Date
October 12 2022
Last Update
August 5 2024
Active Locations (1)
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1
MAUPAIN
Quincy-sous-Sénart, France, 91480