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Ropivacaine Through Continuous Infusion Versus Epidural Morphine for Postoperative Analgesia After Emergency Cesarean Section (ROMANCE)

7. november 2022 opdateret af: University Hospital, Grenoble

The cesarean section is one of the most commonly performed surgeries in the world and it represents 20% of the births in France. Postoperative pain is moderate-to-severe during the first 48 hours after this procedure. Thereby its control is prominent for the medical team in order to shorten the duration of hospital stay as well as to permit an early return to daily activities for these surgical patients.

Pain control after cesarean section is usually based on non-opioids and epidural administration of morphine if an epidural catheter has been previously placed for the procedure. However epidural morphine is associated with a number of side effects. Wound infiltration with local anesthetics has been widely used in the multimodal management of postoperative pain and it may reduce postoperative morphine consumption.

In patients enrolled for emergency cesarean delivery with epidural catheter, the objective of this study will be to compare the analgesia provided by a local anesthetic wound 48-hours infusion through a multiorifice catheter (ropivacaine 2 mg/mL) versus epidural analgesia (epidural morphine bolus). Quality of pain control will be assessed with the measurements of morphine consumption and pain scores at rest and during mobilisation over 48 hours. At 3 months, patients will be interviewed to assess their residual pain and their satisfaction.

It is hypothesized that local anesthetic wound infusion would be non-inferior than epidural morphine analgesia to control pain after cesarean section, and be associated with a reduction of side effects related to the analgesics.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Grenoble, Frankrig
        • Hôpital Couple Enfant - CHU de Grenoble

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Minimum age 18 years
  • ASA-1 and 2 Parturient
  • Emergency Cesarean delivery under epidural anesthesia
  • Suprapubic incision used for cesarean section
  • Functional epidural Catheter before the cesarean decision

(ASA Scores : Physical Status score)

Exclusion Criteria:

  • ASA-3 and 4 Parturient
  • BMI > 35 (before pregnancy)
  • Existing chronic pain
  • Contra-indication to study treatments
  • Chronic use of analgesics or morphinic
  • Preeclampsia
  • Infection
  • < 37 weeks pregnant +/- 3 days

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Continuous wound infusion group
Patients receive analgesia through a multiorifice wound catheter connected to ropivacaine infusion. Saline solution is given in the epidural bolus.
Medicin: Ropivacain
Aktiv komparator: Epidural morphine group
Patients receive epidural analgesia through an epidural bolus of morphine. Saline solution is perfused through the wound catheter.
Medicin: Morfin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain score during mobilization
Tidsramme: at 24 hours
Visual analog scale for pain while the patient moves from lying to sitting
at 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain score at rest
Tidsramme: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Visual analog scale for pain while the patient is at rest
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Pain score during mobilization
Tidsramme: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Visual analog scale for pain while the patient moves from lying to sitting
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
The incidence of morphine side effects: nausea, vomiting, pruritus
Tidsramme: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
At every time points, side effects will be recorded
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Duration of Indwelling Urethral Catheters
Tidsramme: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
At ever time points, the presence of urethral catheter will be recorded and total duration will be compared.
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Recovery of bowel function
Tidsramme: at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
At ever time points, patients will be asked whether they recovered bowel function and total duration to recover bowel function will be compared.
at 2, 6(+/-1h), 12(+/-1h), 24(+/-2h), and 48 hours (+/-3h)
Morphine consumption dose
Tidsramme: During hospital stay (an average of 3 days)
Total dose of morphine consumed for pain management after the epidural bolus
During hospital stay (an average of 3 days)
Parturient satisfaction score
Tidsramme: at 48 hours
Satisfaction about pain management and breastfeeding
at 48 hours
Complications during wound-catheter removal
Tidsramme: at 48 hours
Fever, pain, difficulties and infection at removal
at 48 hours
Delay between birth and breastfeeding
Tidsramme: During hospital stay (an average of 3 days)
During hospital stay (an average of 3 days)
Duration of stay
Tidsramme: Hospital stay (an average of 3 days)
Hospital stay (an average of 3 days)
Residual pain
Tidsramme: 3 months
Numeric Rating Scale for Pain by phone interview
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Grenoble

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2015

Primær færdiggørelse (Faktiske)

28. august 2021

Studieafslutning (Faktiske)

28. december 2021

Datoer for studieregistrering

Først indsendt

1. april 2015

Først indsendt, der opfyldte QC-kriterier

6. april 2015

Først opslået (Skøn)

7. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2022

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Eudract 2014-002044-41

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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