Comparison of Two Analgesic Strategies After Scheduled Caesarean

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status and phase: Completed; Phase 4

Conditions: Analgesia

Treatments: Drug: Morphine; Drug: Sodium Chloride Injection; Drug: Rachianesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04755712

2020-A03334-35

Details and patient eligibility

About

To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.

Full 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.

Enrollment: 104 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

ropivacaine in quadratum lumburum block 2

Experimental group

Description:

Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.

Treatment:

Drug: Rachianesthesia

Drug: Morphine

Intrathecal morphine

Active Comparator group

Description:

Morphine will be administrated in intrathecal

Treatment:

Drug: Rachianesthesia

Drug: Sodium Chloride Injection

Drug: Morphine