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Completed

NCT Number: NCT04755712

Comparison of Two Analgesic Strategies After Scheduled Caesarean

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

MAUPAIN

Quincy-sous-Sénart, 91480, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Rachianesthesia

Drug

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

Other names: Bupivacaine and sufentanil

sodium chloride injection

Drug

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

Other names: sham-QLB2

Morphine

Drug

Morphine via pump (patient controlled analgesia)

Other names: injection of morphine

Primary outcomes

  1. 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

  1. Characteristics of postoperative pain using a visual analogic scale

    Time frame: 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

    Time frame: 2 days

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

  3. Cumulative quantity of morphine received postoperatively via pump

    Time frame: 2 days

    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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2021
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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