Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine
Overview
- Phase
- Phase 4
- Intervention
- Rachianesthesia
- Conditions
- Analgesia
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Cumulative quantity of morphine received postoperatively via pump
- Status
- Completed
- Last Updated
- last year
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.
Investigators
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;
Arms & Interventions
ropivacaine in quadratum lumburum block 2
Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.
Intervention: Rachianesthesia
ropivacaine in quadratum lumburum block 2
Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.
Intervention: Morphine
Intrathecal morphine
Morphine will be administrated in intrathecal
Intervention: Rachianesthesia
Intrathecal morphine
Morphine will be administrated in intrathecal
Intervention: Sodium Chloride Injection
Intrathecal morphine
Morphine will be administrated in intrathecal
Intervention: Morphine
Outcomes
Primary Outcomes
Cumulative quantity of morphine received postoperatively via pump
Time Frame: 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 Outcomes
- Cumulative quantity of morphine received postoperatively via pump(2 days)
- Characteristics of postoperative pain using a visual analogic scale(2 days)
- Side effects of the two analgesic strategies(2 days)