Analgesia
Conditions
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 superiority of ropivacaine in square lumbar block versus intrathecal morphine, on the efficacy of post-operative analgesia, following a scheduled caesarean.
Interventions
DRUGRachianesthesia
Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)
Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound (sham-QLB2).
DRUGMorphine
Morphine via pump (patient controlled analgesia)
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative quantity of morphine received postoperatively via pump | 1 day | The main objective of the study is to demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of postoperative pain using a visual analogic scale | 2 days | Evaluate the characteristics of postoperative pain in both groups with the use of a visual analog scale |
| Side effects of the two analgesic strategies | 2 days | Evaluate the side effects of the two analgesic strategies reported in a case report form |
| Cumulative quantity of morphine received postoperatively via pump | 2 days | Demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean. |
Countries
France
Outcome results
None listed