Comparison of Two Analgesic Strategies After Scheduled Caesarean

GCS Ramsay Santé pour l'Enseignement et la Recherche104 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

104

Conditions

Analgesia

Interventions

RachianesthesiaDRUG

Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)

Sodium Chloride InjectionDRUG

Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound ("sham-QLB2").

MorphineDRUG

Morphine via pump (patient controlled analgesia)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

MAUPAIN

Quincy-sous-Sénart, France

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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

Time frame: 2 days

Side effects of the two analgesic strategies

Evaluate the side effects of the two analgesic strategies reported in a case report form

Time frame: 2 days

Cumulative quantity of morphine received postoperatively via pump

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.

Time frame: 2 days

Data from ClinicalTrials.gov

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