Comparison of Two Analgesic Strategies After Scheduled Caesarean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2022-10-12

Brief Summary

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

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Detailed Description

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ropivacaine in quadratum lumburum block 2

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

Group Type EXPERIMENTAL

Rachianesthesia

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

Morphine via pump (patient controlled analgesia)

Intrathecal morphine

Morphine will be administrated in intrathecal

Group Type ACTIVE_COMPARATOR

Rachianesthesia

Intervention Type DRUG

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

Sodium Chloride Injection

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

Morphine via pump (patient controlled analgesia)

Interventions

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Rachianesthesia

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

Intervention Type DRUG

Sodium Chloride Injection

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

Intervention Type DRUG

Morphine

Morphine via pump (patient controlled analgesia)

Intervention Type DRUG

Other Intervention Names

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Bupivacaine and sufentanil sham-QLB2 injection of morphine

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No