NCT04755712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2022

Completed
Last Updated

August 5, 2024

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

February 8, 2021

Last Update Submit

August 1, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (3)

  • Characteristics of postoperative pain using a visual analogic scale

    2 days

  • Side effects of the two analgesic strategies

    2 days

  • Cumulative quantity of morphine received postoperatively via pump

    2 days

Study Arms (2)

ropivacaine in quadratum lumburum block 2

EXPERIMENTAL

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

Drug: RachianesthesiaDrug: Morphine

Intrathecal morphine

ACTIVE COMPARATOR

Morphine will be administrated in intrathecal

Drug: RachianesthesiaDrug: Sodium Chloride InjectionDrug: Morphine

Interventions

RachianesthesiaDRUG

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

Also known as: Bupivacaine and sufentanil
Intrathecal morphineropivacaine in quadratum lumburum block 2
Sodium Chloride InjectionDRUG

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

Also known as: sham-QLB2
Intrathecal morphine
MorphineDRUG

Morphine via pump (patient controlled analgesia)

Also known as: injection of morphine
Intrathecal morphineropivacaine in quadratum lumburum block 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy less than 37 weeks with amenorrhea;
  • Multiple pregnancy;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAUPAIN

Quincy-sous-Sénart, 91480, France

Location

Related Publications (1)

  • Giral T, Delvaux BV, Huynh D, Morel B, Zanoun N, Ehooman F, Garnier T, Maupain O. Posterior quadratus lumborum block versus intrathecal morphine analgesia after scheduled cesarean section: a prospective, randomized, controlled study. Reg Anesth Pain Med. 2026 Jan 5;51(1):82-89. doi: 10.1136/rapm-2024-105454.

    PMID: 39237149DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

BupivacaineSufentanilSodium ChlorideMorphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 16, 2021

Study Start

March 22, 2021

Primary Completion

October 12, 2022

Study Completion

October 12, 2022

Last Updated

August 5, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)