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Comparison of Two Analgesic Strategies After Scheduled Caesarean

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Recruiting
CT.gov ID
NCT04755712
Collaborator
(none)
104
Enrollment
1
Location
2
Arms
17.3
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine
Actual Study Start Date :
Mar 22, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ropivacaine in quadratum lumburum block 2

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

Drug: Rachianesthesia
Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)
Other Names:
  • Bupivacaine and sufentanil

    • Drug: Morphine
    Morphine via pump (patient controlled analgesia)
    Other Names:
  • injection of morphine

    		•
    Active Comparator: Intrathecal morphine

    Morphine will be administrated in intrathecal

    Drug: Rachianesthesia
    Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)
    Other Names:
  • Bupivacaine and sufentanil

    • Drug: Sodium Chloride Injection
    Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound ("sham-QLB2").
    Other Names:
  • sham-QLB2

    • Drug: Morphine
    Morphine via pump (patient controlled analgesia)
    Other Names:
  • injection of morphine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative quantity of morphine received postoperatively via pump [2 days]

      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 Outcome Measures

    1. Characteristics of postoperative pain using a visual analogic scale [2 days]

      Evaluate the characteristics of postoperative pain in both groups with the use of a visual analog scale

    2. Side effects of the two analgesic strategies [2 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MAUPAIN Quincy-sous-Sénart France 91480

    Sponsors and Collaborators

    • GCS Ramsay Santé pour l'Enseignement et la Recherche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GCS Ramsay Santé pour l'Enseignement et la Recherche
    ClinicalTrials.gov Identifier:
    NCT04755712
    Other Study ID Numbers:
    • 2020-A03334-35
    First Posted:
    Feb 16, 2021
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sufentanil
    Morphine
    Bupivacaine

    Study Results

    No Results Posted as of Apr 27, 2022