Comparison of Two Analgesic Strategies After Scheduled Caesarean

Study Overview
=================
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.

Official Title
-----------------
Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Rachianesthesia
* Drug: Sodium Chloride Injection
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine in quadratum lumburum block 2<br>Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian. | Drug: Rachianesthesia<br>* Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)<br>* Other names: Bupivacaine and sufentanil;Drug: Morphine<br>* Morphine via pump (patient controlled analgesia)<br>* Other names: injection of morphine;|
| Active Comparator: Intrathecal morphine<br>Morphine will be administrated in intrathecal | Drug: Rachianesthesia<br>* Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)<br>* Other names: Bupivacaine and sufentanil;Drug: Sodium Chloride Injection<br>* Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound (sham-QLB2).<br>* Other names: sham-QLB2;Drug: Morphine<br>* Morphine via pump (patient controlled analgesia)<br>* Other names: injection of morphine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative quantity of morphine received postoperatively via pump | 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. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of postoperative pain using a visual analogic scale | Evaluate the characteristics of postoperative pain in both groups with the use of a visual analog scale | 2 days | 
| Side effects of the two analgesic strategies | Evaluate the side effects of the two analgesic strategies reported in a case report form | 2 days |