Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care (VSD)
Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.
In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.
As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.
In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.
However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Amiens, Frankrike, 80054
- CHU Amiens
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Beauvais, Frankrike, 60000
- CH Beauvais
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient aged 18 to 80 years
- Patients with biliary pathology requiring cholecystectomy
- Patients with signed consent
- Patient eligible to outpatient care
- No allergy to Naropin
- Support by laparoscopy
- Patients affiliated to a social security s
Exclusion Criteria:
- Contraindications for laparoscopy
- Contraindications to outpatient surgery
- Patients with an allergy to paracetamol or tramadol
- Patient with an addiction to painkillers and / or alcohol
- Patient with a disease causing chronic pain
- Patient using analgesics bearing 1 , 2 or 3 chronically
- Pregnant or breastfeeding women , of reproductive age without effective contraception
- Minor Patient,
- Contraindication to surgery,
- Physical or psychological state does not allow the patient's participation in the study ,
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Ropivacaine
Ropivacaine 7.5 mg/mL administration
|
Ropivacaine administration
|
|
Placebo komparator: Sodium chloride
NaCl 0.9% administration
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Sodium chloride administration
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pain measured by visual analog scale (VAS)
Tidsramme: between first postoperative day and 6th postoperative day
|
between first postoperative day and 6th postoperative day
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
global pain measured by BPI (Brief Pain Inventory) scale
Tidsramme: 30th postoperative day
|
30th postoperative day
|
|
analgesics use
Tidsramme: 30th postoperative day
|
30th postoperative day
|
|
global morbidity
Tidsramme: 30th postoperative day
|
30th postoperative day
|
|
specific complications for each treatment
Tidsramme: 30th postoperative day
|
30th postoperative day
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jean-Marc REGIMBEAU, MD, PhD, CHU Amiens
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PI2015_843_0020
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