Virkning af specifik overvågning af intraoperativ analgesi under generel anæstesi på kroniske smerter efter ovariecancerkirurgi (MONIALC)
Indvirkning af specifik overvågning af intraoperativ analgesi under generel anæstesi på kroniske smerter efter ovariecancerkirurgi. MONIALC-undersøgelsen.
This is a single-center, randomized, phase II, non-comparative, single-blind clinical study that will determine whether morphine reduction through intraoperative monitoring by ANI (Analgesia Nociception Index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
Before inclusion,all eligibility criteria will be verified, VAS pain score and VAS anxiety will be performed.
The surgical procedure for ovarian carcinoma will be performed by laparotomy and the intraoperative monitoring of nociception wil depend of the randomization arm : Intraoperative ANI monitoring of nociception (experimental arm) versus no specific monitoring of nociception (control arm). The total dose of opioids (in micrograms) received by the patients will be recorded at the end of the surgery.
VAS pain score will be performed immediately postoperatively and at three months after the intervention. A DN4 questionnaire (neuropathic pain) will be evaluated at three months after the intervention.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bordeaux, Frankrig, 33076
- Institut Bergonié
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Woman aged 18 years and over.
- Histologically proven or strongly suspected ovarian carcinoma.
- Indication for laparotomy surgery with xyphopubic incision.
- Acceptance of epidural anesthesia.
- Pain score ≤ 3 (VAS or Numeric Verbal Scale).
- Free and informed consent.
- Patient affiliated with a French social security scheme in accordance with French law on research involving human participants.
Exclusion Criteria:
- Heart rhythm disturbances.
- History of Cerebral Vascular Accident (CVA).
- History of epilepsy.
- Wearing a pacemaker.
- Receiving morphine treatment preoperatively.
- Medical contraindication to an epidural.
- Patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons.
- Patient placed under guardianship or curatorship.
- Patient already included in the present study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Arm A: Eksperimentel gruppe med intraoperativ ANI-monitorering af nociception
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For the experimental group (arm A), the sufentanil doses are adjusted to maintain an ANI between 50 and 70. Morphine doses are adjusted from 0.05 to 0.05 µg / ml. Intraoperative data will be collected for ANI, TIVA and hemodynamics. |
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Andet: Arm B: Kontrolgruppe uden ANI intraoperativ monitorering af nociception
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For the control group (arm B), adjustments to the opioid doses are made in relation to the hemodynamic reactions of the patient and the operating times. Intraoperative data will be collected for TIVA and hemodynamics. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of patients with a pain score on the self-assessment VAS > 4, three months after the surgery.
Tidsramme: 3 months after surgery
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The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant. |
3 months after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Arm A: total dosis opioider modtaget intraoperativt
Tidsramme: Kirurgi
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Kirurgi
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Arm B: total dosis opioider modtaget intraoperativt
Tidsramme: Kirurgi
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Kirurgi
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Arm A: andel af patienter med en DN4 spørgeskemascore > 4, tre måneder efter operationen
Tidsramme: 3 måneder efter operationen
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3 måneder efter operationen
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Arm B: Arm A: andel af patienter med en DN4 spørgeskemascore > 4, tre måneder efter operationen
Tidsramme: 3 måneder efter operationen
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3 måneder efter operationen
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Arm A : Patients' pain score on the VAS immediately postoperatively
Tidsramme: within one hour of extubation
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The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant. |
within one hour of extubation
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Arm B : Patients' pain score on the VAS immediately postoperatively
Tidsramme: within one hour of extubation
|
The Visual Analog Scale (VAS) is a validated, reliable and reproducible tool. The VAS will be used to measure pain. This self-assessment scale allows the patient to evaluate his or her pain from 0 to 10 "0=No pain" to "10=Maximum imaginable pain ". A pain VAS score of 4 and above is considered clinically significant. |
within one hour of extubation
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i det endokrine system
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kønssygdomme, kvindelige
- Neoplasmer i endokrine kirtler
- Ovariesygdomme
- Adnexale sygdomme
- Genitale neoplasmer, kvindelige
- Gonadale lidelser
- Ovariale neoplasmer
Andre undersøgelses-id-numre
- IB 2020-04
- 2020-A02767-32 (Anden identifikator: ANSM IDRCB number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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